FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® PLASTIC URINE COLLECTION CUP
MDR report key: 7007038
·
Received November 7, 2017
Report
- Report Number
- 1917413-2017-00223
- Event Type
- Malfunction
- Date Received
- November 7, 2017
- Date of Event
- August 24, 2015
- Report Date
- October 31, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JTW
- PMA / PMN Number
- K790366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BD VACUTAINER® PLASTIC URINE COLLECTION CUP WERE LEAKING. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787812 | BD VACUTAINER® PLASTIC URINE COLLECTION CUP | COLLECTION CUP | JTW | BECTON, DICKINSON & CO. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |