FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® URINE COLLECTION CUP
MDR report key: 7576374
·
Received June 6, 2018
Report
- Report Number
- 1917413-2018-01952
- Event Type
- Malfunction
- Date Received
- June 6, 2018
- Date of Event
- August 16, 2016
- Report Date
- May 30, 2018
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- KDW
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. 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® URINE COLLECTION CUP EXPERIENCED LEAKAGE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418240 | BD VACUTAINER® URINE COLLECTION CUP | SPECIMEN TRANSPORT AND STORAGE CONTAINER | KDW | BECTON, DICKINSON & CO. | 5355555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |