FDA Adverse Event
Malfunction
Summary report: N
GROSHONG 8 FR S/L CV CATHETER
MDR report key: 1230853
·
Received November 6, 2008
Report
- Report Number
- 3006260740-2008-00190
- Event Type
- Malfunction
- Date Received
- November 6, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 13, 2008
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K831386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED, THE CUFF WAS MISSING, IT IS NOT SURE WHERE THE CUFF IS. THE PT HAS BEEN FINE. IT'S BEEN DOCUMENTED IN THE PTS NOTES THAT THE CUFF WAS NOT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GROSHONG 8 FR S/L CV CATHETER | LJS | C. R. BARD INC. (BASD) | RERA0249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |