FDA Adverse Event
Malfunction
Summary report: N
28CM DIALYSIS CATHETER
MDR report key: 643840
·
Received September 29, 2005
Report
- Report Number
- 1720496-2005-00173
- Event Type
- Malfunction
- Date Received
- September 29, 2005
- Date of Event
- August 30, 2005
- Report Date
- September 8, 2005
- Manufacturer
- C.R. BARD, INC.(BASD)
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
LEAKAGE FROM THE CATHETER. THE CATHETER HAS BEEN IN USE SINCE 1/21/2005. WHEN FLUSHING THE CATHETER IN 2005. THE PT SUDDENLY HAD A PAIN ON THE LEFT SIDE WHERE THE CATHETER WAS PLACED. THE CATHETER WAS WITHDRAWN AND A HOLE COULD BE SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 28CM DIALYSIS CATHETER | IMPLANTED BLOOD ACCESS DEVICE | DQO | C.R. BARD, INC.(BASD) | * | 22EO6078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |