FDA Adverse Event
Malfunction
Summary report: N
23 G X .75 IN BD VACUTAINER® PBBCS WITH 12 IN TUBING AND LUER
MDR report key: 7059955
·
Received November 27, 2017
Report
- Report Number
- 1024879-2017-00508
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- July 20, 2016
- Report Date
- October 24, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903673421
- PMA / PMN Number
- K030573
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS THIS IS A CONFIRMED COMPLAINT FOR LOT# 6132861 FOR TUBING LEAKAGE, A DHR REVIEW IS NOT REQUIRED. REFER TO CAPA (B)(4). (B)(4) REPRESENTATIVE SAMPLES WERE RETURNED BY CUSTOMER. SAMPLES WERE PRESSURIZED LEAK TESTED WITH NO DEFECTS IDENTIFIED. THIS COMPLAINT CANNOT BE CONFIRMED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT BLOOD LEAKED FROM TUBING JUST ABOVE THE WHITE CONNECTOR CLOSEST TO THE RECEIVING NEEDLE FROM A 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER. NO INJURY, BLOOD EXPOSURE, OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838761 | 23 G X .75 IN BD VACUTAINER® PBBCS WITH 12 IN TUBING AND LUER | BLOOD COLLECTOR | JKA | BECTON, DICKINSON & CO., (BD) | 6132861 | 00382903673421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |