FDA Adverse Event
Malfunction
Summary report: N
HEMOGLIDE KIT, PC-2
MDR report key: 1277071
·
Received December 12, 2008
Report
- Report Number
- 3006260740-2008-00242
- Event Type
- Malfunction
- Date Received
- December 12, 2008
- Date of Event
- October 31, 2008
- Report Date
- November 18, 2008
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K010567
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. (200633).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEMOGLIDE WAS PLACED IN 2007, AND REMOVED IN 2008 AS THE CATHETER HAD CRACKED AND THERE WAS LEAKAGE. WHEN INJECTED THROUGH THE ARTERIAL LUMEN, FLUID WAS LEAKING OUT AT THE BIFURCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOGLIDE KIT, PC-2 | MSD | C. R. BARD, INC. (BASD) | REQA0308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |