Description
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Patient Condition
- A 45-year-old female patient was inserted with a 14Fr Levin tube in the intensive care unit. As the patient was thin, the physician selected a 14Fr tube rather than a 16Fr tube.
- To check that the Levin tube was located inside the stomach, the physician put air in using a syringe and subsequently observed with a stethoscope.
- To double-check that the Levin tube was properly placed in the patient's stomach, a chest X-ray was taken.
Events
- The radiologist failed to find the Levin tube from the patient's chest X-ray image. Refer to Figure (a).
- Normally, the Levine tube would be observed in the chest X-ray image as shown in Figure (b).
Post-event management & Health effect
- Removed the Levin tube for patient safety and inserted another 14Fr tube.
- The patient retook a chest X-ray to check for the right placement of the Levin tube.
- The patient expressed discomfort in the nose area due to repeated insertion.
Investigations (Cause, Improvements)
- Quality manager of the manufacturer detected that the radio-opaque line impregnated was narrower in width and contained smaller amount of barium sulfate at the tip, compared to the Levin tube of the same lot.
- The manufacturer decided to increase the width of the radio-opaque line to 8 mm for the Levin tube.
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Annex
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Code
|
#
|
%
|
A |
A01 - Lower Level Codes
A01 |
Patient Device Interaction Problem |
21 |
|
A0101 |
Patient-Device Incompatibility |
4 |
|
A010101 |
Biocompatibility |
3 |
|
A010103 |
Inadequacy of Device Shape and/or Size |
1 |
|
A0102 |
Osseointegration Problem |
2 |
|
|
31
|
26.7%
|
A |
A02 - Lower Level Codes
A02 |
Manufacturing, Packaging or Shipping Problem |
15 |
|
A0201 |
Product Quality Problem |
6 |
|
A0202 |
Defective Component |
1 |
|
A0203 |
Defective Device |
6 |
|
|
28
|
24.1%
|
A |
A03 - Lower Level Codes
A03 |
Chemical Problem |
9 |
|
A030201 |
Clumping in Device or Device Ingredient |
1 |
|
A030205 |
Particulates |
1 |
|
A0303 |
Improper Chemical Reaction |
3 |
|
|
14
|
12.1%
|
A |
A04 - Lower Level Codes
A04 |
Material Integrity Problem |
3 |
|
A0405 |
Degraded |
1 |
|
A0409 |
Material Opacification |
6 |
|
|
10
|
8.6%
|
A |
A06 - Lower Level Codes
A06 |
Optical Problem |
5 |
|
A0602 |
Optical Decentration |
1 |
|
|
6
|
5.2%
|
A |
A05 , A07 , A15 , A23 , A20 , A24 , A26 , A21 , A27 , A08 , A09 , A17 , A19 |
27 total:116
|
23.3%
|
B |
B01 - Lower Level Codes
B01 |
Testing of Actual/Suspected Device |
24 |
|
|
24 |
34.8%
|
B |
B02 - Lower Level Codes
B02 |
Testing of Device from Same Lot/Batch Retained by Manufacturer |
19 |
|
|
19 |
27.5%
|
B |
B03 - Lower Level Codes
B03 |
Testing of Device from Same Lot/Batch Returned from User |
10 |
|
|
10 |
14.5%
|
B |
B04 - Lower Level Codes
B04 |
Testing of Device from Other Lot/Batch Retained by Manufacturer |
4 |
|
|
4 |
5.8%
|
B |
B12 - Lower Level Codes
|
3 |
4.3%
|
B |
B07 , B14 , B21 , B05 , B06 , B13 |
9 total:69 |
13.0%
|
C |
C06 - Lower Level Codes
C06 |
Material and/or Chemical Problem Identified |
17 |
|
C0602 |
Inappropriate Material |
1 |
|
C060201 |
Improper Composition/ Concentration |
3 |
|
C0603 |
Inadequate Physicochemical Properties |
4 |
|
C0606 |
Tolerance Stack-Up |
2 |
|
| 27 |
45.8%
|
C |
C16 - Lower Level Codes
C16 |
Manufacturing Process Problem Identified |
8 |
|
C1604 |
Maintenance of Manufacturing Machinery |
1 |
|
| 9 |
15.3%
|
C |
C01 - Lower Level Codes
C01 |
Biological Problem Identified |
4 |
|
C0101 |
Biocompatibility Problem Identified |
1 |
|
| 5 |
8.5%
|
C |
C07 - Lower Level Codes
C0707 |
Incorrect Dimension |
4 |
|
| 4 |
6.8%
|
C |
C09 - Lower Level Codes
C09 |
Clinical Imaging Problem Identified |
4 |
|
| 4 |
6.8%
|
C |
C22 , C13 , C08 , C14 , C17 , C03 , C04 |
10 total:59 |
16.9%
|
D |
D01 - Lower Level Codes
D01 |
Cause Traced to Device Design |
16 |
|
D0101 |
Design Inadequate for Purpose |
3 |
|
D0102 |
Human Factors Engineering - Device Difficult to Operate |
1 |
|
D0106 |
Design Change Validation Inadequate |
1 |
|
| 21 |
37.5%
|
D |
D03 - Lower Level Codes
D03 |
Cause Traced to Manufacturing |
9 |
|
D0301 |
Manufacturing Deficiency |
4 |
|
D0302 |
Quality Control Deficiency |
8 |
|
| 21 |
37.5%
|
D |
D02 - Lower Level Codes
D02 |
Cause Traced to Component Failure |
5 |
|
| 5 |
8.9%
|
D |
D04 - Lower Level Codes
D04 |
Cause Traced to Transport/Storage |
2 |
|
| 2 |
3.6%
|
D |
D15 - Lower Level Codes
D1501 |
Cause Linked to Device but Unable to Trace More Specifically |
2 |
|
| 2 |
3.6%
|
D |
D09 , D10 , D11 , D16 , D18 |
5 total:56 |
8.9%
|
E |
E24 - Lower Level Codes
E24 |
Others |
4 |
|
E2402 |
Appropriate Term / Code Not Available |
2 |
|
E2403 |
No Clinical Signs, Symptoms or Conditions |
7 |
|
| 13 |
22.8%
|
E |
E07 - Lower Level Codes
E07 |
Respiratory System |
6 |
|
E0745 |
Sinus Perforation |
1 |
|
| 7 |
12.3%
|
E |
E01 - Lower Level Codes
| 7 |
12.3%
|
E |
E10 - Lower Level Codes
E10 |
Gastrointestinal System |
5 |
|
E1020 |
Nausea |
1 |
|
| 6 |
10.5%
|
E |
E21 - Lower Level Codes
E21 |
Procedural Complications |
5 |
|
E2118 |
Unintended Extubation |
1 |
|
| 6 |
10.5%
|
E |
E23 , E17 , E03 , E20 , E22 , E14 , E18 , E02 |
18 total:57 |
31.6%
|
F |
F05 - Lower Level Codes
F05 |
Delay to Treatment/ Therapy |
12 |
|
| 12 |
20.7%
|
F |
F11 - Lower Level Codes
F11 |
Minor Injury/ Illness / Impairment |
9 |
|
| 9 |
15.5%
|
F |
F26 - Lower Level Codes
F26 |
No Health Consequences or Impact |
6 |
|
| 6 |
10.3%
|
F |
F01 - Lower Level Codes
F01 |
Change in Therapeutic Response |
4 |
|
F0101 |
Therapeutic Response Decreased |
1 |
|
| 5 |
8.6%
|
F |
F14 - Lower Level Codes
F14 |
Prolonged Episode of Care |
3 |
|
| 3 |
5.2%
|
F |
F04 , F06 , F10 , F19 , F02 , F03 , F15 , F16 , F18 , F07 , F22 , F08 , F23 , F24 , F12 , F13 |
23 total:58 |
39.7%
|
G |
G01 - Lower Level Codes
G01 |
Biological and Chemical |
10 |
|
G01003 |
Device Ingredient or Reagent |
3 |
|
G01006 |
Test Strip |
1 |
|
| 14 |
26.4%
|
G |
G03 - Lower Level Codes
G03 |
Measurement |
5 |
|
G03008 |
Marker |
5 |
|
| 10 |
18.9%
|
G |
G04 - Lower Level Codes
G04 |
Mechanical |
4 |
|
G04023 |
Catheter |
2 |
|
G04029 |
Coating Material |
1 |
|
G04069 |
Hose |
1 |
|
G04134 |
Tube |
1 |
|
| 9 |
17.0%
|
G |
G05 - Lower Level Codes
G05 |
Optical |
6 |
|
G05007 |
Light Source |
2 |
|
| 8 |
15.1%
|
G |
G07 - Lower Level Codes
G07 |
Others |
5 |
|
G07001 |
Part/Component/Sub-assembly Term not Applicable |
2 |
|
G07002 |
Appropriate Term/Code Not Available |
1 |
|
| 8 |
15.1%
|
G |
G02 , G06 |
4 total:53 |
7.5%
|
X-ray after Levin tube is inserted into the patient's chest
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Ju min Park , Republic of Korea [ 2021-09-01 13:42:08.0]
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Is the method of applying IMDRF in this study correct because visible light is emitted during X-ray imaging?
[6]
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Material integrity problem
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Soo Jeong Choi , Republic of Korea [ 2021-09-01 17:37:06.0]
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Concept of material integrity is not easy for me. I wonder the correct code.
[5]
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Wonderful case.
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Soo Jeong Choi , Republic of Korea [ 2021-09-01 17:50:49.0]
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This case made me thinking! This case is very educated!
[6]
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Very Educational program
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Jieun Lee , Republic of Korea [ 2021-09-10 09:18:30.0]
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Thank you so much :)
[3]
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Levin tube
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María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica [ 2021-09-10 10:57:44.0]
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This case refers to a real probability that may occur
[3]
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You Kyoung Lee , Republic of Korea [ 2021-09-10 14:46:13.0]
Agreed. It happens.
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Levin tube
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Jaeyeong Jang , Republic of Korea [ 2021-09-11 10:46:09.0]
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this case is interesting because of its clinical probability.
[3]
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Jin Kuk Kim , Republic of Korea [ 2021-09-12 12:13:22.0]
Agreed. It's already happens
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Levin tube
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María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica [ 2021-09-12 02:20:41.0]
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It is very important to analyze any case using the IMDRF codes, therefore it is useful to have a integrated perspective of the event
[1]
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Levin tube procedure
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Jin Kuk Kim , Republic of Korea [ 2021-09-12 12:09:14.0]
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Levin tube insertion is mainly done by intern in Korea. In this situation, the intern is very embarrassed because he can't check the Levin tube on X-ray.
[1]
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Levin Tube
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JooMyung Song , Republic of Korea [ 2021-09-12 21:26:15.0]
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This is beneficial trial to have skillset to select proper answer of adverse event reporting in IMDRF
[1]
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Levin Tube
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Ji hyun Kim , Republic of Korea [ 2021-09-13 14:39:47.0]
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This case was very interesting during the conduct as it was very likely to happen in the clinical area.
[1]
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Silicon Levin tube, 14FR
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Jiyun Jeong , Republic of Korea [ 2021-09-13 15:32:17.0]
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Chemical Problem
[1]
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Levin tube
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Pei-Hsuan Huang , The United States [ 2021-09-14 04:25:26.0]
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Chemical Problem
[1]
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Silicon Levin tube, 14FR
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Jeffrey Recustodio , The Philippines [ 2021-09-14 11:48:59.0]
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This case is a real scenario that will happen anytime.
[1]
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Levin tube
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SoonWoo Hong , Republic of Korea [ 2021-09-14 12:58:55.0]
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This is helpful in studying adverse event reporting of IMDRF.
[1]
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Silicon Levin tube, 14FR
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Stevie Lee , Republic of Korea [ 2021-09-14 15:50:32.0]
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This activity is very helpful
[1]
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Silicon Levin tube
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Jang Soonheung , Republic of Korea [ 2021-09-15 11:11:13.0]
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as This activity is very helpful, thamk you
[1]
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Handling of the device not in accordance with specification, prior to use on the patient.
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Jang Soonheung , Republic of Korea [ 2021-09-15 11:18:04.0]
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as This activity is very helpful, thank you
[1]
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This is helpful in studying adverse event reporting of IMDRF.
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Soohyun Nam , Republic of Korea [ 2021-09-15 12:22:54.0]
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This is helpful in studying adverse event reporting of IMDRF.
[2]
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Silicon Levin tube, 14FR
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Nami Migita , The United States [ 2021-09-16 01:05:11.0]
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This case is very helpful.
[2]
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Levin Tube
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YoonSung Kim , Republic of Korea [ 2021-09-16 17:46:40.0]
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This programe is able to make helpful in studying IMDRF.
[1]
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Levin tube case
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Citra Bonnita Putri , Indonesia [ 2021-09-16 21:16:49.0]
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This activity is helpful.
[1]
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Health consequences
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María Del Rocío Peinador Roldán , (Non-APEC) Costa Rica [ 2021-09-16 23:15:30.0]
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Discomfort can be considered "No Health Consequences or Impact"? It is a doubt that I have. Subjective (f.ex:pain) or observed (f.ex:injury)
[1]
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Levin tube
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Chang Hyun Lim , Republic of Korea [ 2021-09-17 16:34:26.0]
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This activity is helpful
[1]
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Silicon Levin tube, 14FR
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Erika Masis , (Non-APEC) Costa Rica [ 2021-09-20 09:45:53.0]
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This case is very helpful.
[2]
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Silicon Levin tube, 14FR
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Erika Masis , (Non-APEC) Costa Rica [ 2021-09-20 10:15:54.0]
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This case is very helpful.
[2]
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Silicon Levin tube, 14FR
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Erika Masis , (Non-APEC) Costa Rica [ 2021-09-20 10:22:09.0]
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This case is very helpful.
[2]
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Levin tube
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Jang Hyejung , Republic of Korea [ 2021-09-20 15:33:57.0]
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It's very good case.
[2]
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Silicon Levin tube, 14FR
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Regina Li , Hong Kong [ 2021-09-21 11:09:43.0]
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This case is very helpful.
[2]
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Silicon Levin tube, 14FR
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Seontae Kim , Republic of Korea [ 2021-09-21 16:13:48.0]
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Thank you and this case is helpful
[0]
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This activity is helpful
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Jiyeon Kin , Republic of Korea [ 2021-09-21 23:03:10.0]
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This activity is very helpful
[0]
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