FDA Adverse Event
Malfunction
Summary report: N
2.7 ML, 13 X 75 MM BD VACUTAINER® CITRATE TUBES, CLEAR BD HEMOGARD¿ CLOSURES
MDR report key: 7059706
·
Received November 27, 2017
Report
- Report Number
- 1917413-2017-00336
- Event Type
- Malfunction
- Date Received
- November 27, 2017
- Date of Event
- December 8, 2015
- Report Date
- November 2, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 00382903643059
- PMA / PMN Number
- K013971
- 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 REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5161724. 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 HEMOGARD CAP OF 2.7 ML, 13 X 75 MM BD VACUTAINER® PLASTIC CITRATE TUBE WITH CLEAR BD HEMOGARD¿ CLOSURE WAS CRACKED. NO INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841152 | 2.7 ML, 13 X 75 MM BD VACUTAINER® CITRATE TUBES, CLEAR BD HEMOGARD¿ CLOSURES | CITRATE SERUM TUBES | JKA | BECTON, DICKINSON & CO. | 5161724 | 00382903643059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |