FDA Adverse Event
Malfunction
Summary report: N
BECTON, DICKINSON & CO.
MDR report key: 1345973
·
Received March 16, 2009
Report
- Report Number
- MW5010353
- Event Type
- Malfunction
- Date Received
- March 16, 2009
- Date of Event
- March 4, 2009
- Report Date
- March 16, 2009
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAD A TUNNELED RIGHT IJ CATHETER FOR HEMODIALYSIS, PLACED IN 2008. POST DIALYSIS LABS DRAWN FROM CATHETER USING LUER ADAPTER VACUTAINER. DURING REMOVAL LUER ADAPTER SNAPPED OFF INSIDE CATHETER PORT. SURGEON AND STAFF UNABLE TO REMOVE MANUALLY. PT TO OR FOR SURGICAL EXCHANGE OF CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BECTON, DICKINSON & CO. | MULTISAMPLE VACUTAINER, LUER ADAPTER | JKA | BECTON, DICKINSON & CO. | 8079938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |