FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M
MDR report key: 7601089
·
Received June 14, 2018
Report
- Report Number
- 9617032-2018-01834
- Event Type
- Malfunction
- Date Received
- June 14, 2018
- Date of Event
- June 30, 2016
- Report Date
- May 22, 2018
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903643054
- PMA / PMN Number
- K013971
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDICAL DEVICE LOT #: 6011749. MEDICAL DEVICE EXPIRATION DATE: 10/31/2016. DEVICE MANUFACTURE DATE: 01/11/2016. (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M SHOWED UNDERFILL. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442148 | BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 6028908 | 50382903643054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |