FDA Adverse Event
Malfunction
Summary report: N
19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD
MDR report key: 2896822
·
Received December 28, 2012
Report
- Report Number
- 3006260740-2012-00474
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 6, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K030020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REWG0695 SHOWED EIGHT OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER (391593, 403561, 403565, 404134, 410159, 416306, 416307, 417748).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR IMPLANTED A LONG TERM CATHETER FROM RIGHT INTERNAL JUGULAR IN (B)(6) 2012. FROM THAT TIME TO (B)(6) 2012, HEMODIALYSIS IS SUCCESSFUL. (B)(6) 2012, THE DOCTOR FOUND THE PATIENT'S CATHETER OUT OF POSITION 1 CM WHEN HE WAS IN HEMODIALYSIS. THE DOCTOR CHECKED AND CONFIRMED THAT THE CUFF WAS STILL IN PATIENT'S BODY. THE CATHETER SEPARATED FROM THE CUFF. THE DOCTOR HAS TO CHANGE A NEW CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD | MSD | C. R. BARD INC. (BASD) | REVG1020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |