FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® PLASTIC URINE COLLECTION CUP
MDR report key: 7083038
·
Received December 5, 2017
Report
- Report Number
- 1917413-2017-00328
- Event Type
- Malfunction
- Date Received
- December 5, 2017
- Date of Event
- February 17, 2016
- Report Date
- November 8, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JTW
- PMA / PMN Number
- K790366
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS:BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® PLASTIC URINE COLLECTION CUP WAS FOUND LEAKING AT THE LID. NO INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862247 | BD VACUTAINER® PLASTIC URINE COLLECTION CUP | URINE COLLECTION CUP | JTW | BECTON, DICKINSON & CO. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |