FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
MDR report key: 7077239
·
Received December 1, 2017
Report
- Report Number
- 1024879-2017-00832
- Event Type
- Malfunction
- Date Received
- December 1, 2017
- Date of Event
- August 3, 2016
- Report Date
- November 2, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903672905
- PMA / PMN Number
- K991088
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: PHOTOS WERE RECEIVED AND EVALUATED SHOWING DEFECT. SAMPLES FROM THE SAME LOT WERE VISUALLY INSPECTED AND LEAK TESTED SHOWING NO DEFECT. ACTUAL DEVICE WAS NOT RECEIVED AND EVALUATED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5211931. CONCLUSION:WITHOUT AN ACTUAL SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER LEAKED BLOOD DURING A BLOOD COLLECTION PROCEDURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853940 | BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 5211931 | 00382903672905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |