FDA Adverse Event
Malfunction
Summary report: N
URINE COLLECTION KIT BD VACUTAINER® 4 ML PLASTIC
MDR report key: 7072106
·
Received November 30, 2017
Report
- Report Number
- 1917413-2017-00286
- Event Type
- Malfunction
- Date Received
- November 30, 2017
- Date of Event
- June 10, 2016
- Report Date
- November 2, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JSM
- UDI-DI
- 00382903649532
- PMA / PMN Number
- K024240
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWS THE COMPLAINT OF A PACKAGE THAT IS OPEN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6061866. 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 URINE COLLECTION KIT BD VACUTAINER® 4 ML PLASTIC PACKAGING WAS TORN. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852814 | URINE COLLECTION KIT BD VACUTAINER® 4 ML PLASTIC | URINE COLLECTION SET | JSM | BECTON, DICKINSON & CO. | 6061866 | 00382903649532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |