FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER®PLUS PLASTIC CITRATE TUBE
MDR report key: 7071076
·
Received November 30, 2017
Report
- Report Number
- 1917413-2017-00248
- Event Type
- Malfunction
- Date Received
- November 30, 2017
- Date of Event
- November 14, 2015
- Report Date
- October 31, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 00382903630806
- PMA / PMN Number
- K013971
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- 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 # 5210903. 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 SOME OF THE BD VACUTAINER®PLUS PLASTIC CITRATE TUBE 13X75MM,1.8ML CAPS ARE LOOSE AND COMING OFF. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852224 | BD VACUTAINER®PLUS PLASTIC CITRATE TUBE | BLOOD SPECIMEN COLLECTION DEVICE. | JKA | BECTON, DICKINSON & CO. | 5210903 | 00382903630806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |