FDA Adverse Event
Other
Summary report: N
OVERPRESSURE SAFETY VALVE
MDR report key: 129470
·
Received October 29, 1997
Report
- Report Number
- 1222008-1997-00166
- Event Type
- Other
- Date Received
- October 29, 1997
- Date of Event
- July 3, 1997
- Report Date
- July 11, 1997
- Manufacturer
- BARD VASCULAR SYSTEM
- Product Code
- MNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE ONEWAY (DUCKBILL) VALVE IN THE OPS VALVE IS STUCK SHUT AND IS THEREFORE NOT ALLOWING FLUID FLOW THROUGH THE OPS VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVERPRESSURE SAFETY VALVE | OPS VALVE | MNJ | BARD VASCULAR SYSTEM | NA | 43LGB110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |