FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
MDR report key: 7576086
·
Received June 6, 2018
Report
- Report Number
- 1024879-2018-01944
- Event Type
- Malfunction
- Date Received
- June 6, 2018
- Date of Event
- September 14, 2016
- Report Date
- June 8, 2018
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679831
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MEDICAL DEVICE LOT # IS CORRECTED TO 6092544.
Additional Manufacturer Narrative · 1
BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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 THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD BUBBLES IN THE GEL. NO SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418910 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 6092544 | 50382903679831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |