FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
MDR report key: 7078009
·
Received December 3, 2017
Report
- Report Number
- 9617032-2017-00252
- Event Type
- Malfunction
- Date Received
- December 3, 2017
- Date of Event
- May 4, 2016
- Report Date
- November 1, 2017
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 00382903679539
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER PROVIDED ONE PHOTOGRAPH CONFIRMING THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT #: 6011688 FOR THIS INCIDENT. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THERE WAS INSUFFICIENT EVIDENCE TO CATEGORIZE THE DEFECT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STOPPERS ON SIX OF THE 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBES WERE DEFECTIVE. A PHOTOGRAPH RETURNED SHOWED THE TOPS OF THE SIX TUBES HAD CRACKS IN THE CENTER OF THEIR STOPPERS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857284 | 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 |