FDA Adverse Event
Malfunction
Summary report: N
HEMOGLIDE KIT, PC-2
MDR report key: 1963447
·
Received December 20, 2010
Report
- Report Number
- 3006260740-2010-00380
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Report Date
- December 13, 2010
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K010567
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.
Description of Event or Problem · 1
THE CATHETER STARTED TO LEAK SO THEY HAD TO REPLACE WITH A NEW ONE. THE LEAKAGE IS NEXT TO THE CUFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOGLIDE KIT, PC-2 | MSD | C. R. BARD, INC. (BASD) | RESL0254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |