FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
MDR report key: 7462788
·
Received April 25, 2018
Report
- Report Number
- 9617032-2018-00928
- Event Type
- Malfunction
- Date Received
- April 25, 2018
- Date of Event
- March 20, 2017
- Report Date
- April 20, 2018
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679558
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6011721. MEDICAL DEVICE EXPIRATION DATE: 07/31/2017. DEVICE MANUFACTURE DATE: 01/11/2016. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES "SSTII-367955-UNDERFILL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300121 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 5295526 | 50382903679558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |