FDA Adverse Event
Malfunction
Summary report: N
16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
MDR report key: 7058752
·
Received November 27, 2017
Report
- Report Number
- 9617032-2017-00234
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- April 22, 2016
- Report Date
- October 30, 2017
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 00382903679539
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. RESULTS: A SAMPLE WAS RETURNED FOR EVALUATION. RETURNED MATERIALS AND PHOTOS SHOWED REPORTED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6011688. CONCLUSION: PHOTOS AND SAMPLES WERE RETURNED FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. BASED ON THE RETURNED PHOTOGRAPH AND SAMPLES, BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBES HAD DEFECTIVE MOLDING ON THE STOPPER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840791 | 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE | BLOOD COLLECTION TUBE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 6011688 | 00382903679539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |