FDA Adverse Event
Malfunction
Summary report: N
MALLINCKRODT THREE WAY STOPCOCK
MDR report key: 1202064
·
Received October 15, 2008
Report
- Report Number
- 2936999-2008-00509
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 9, 2008
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- FMG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN HAS REQUESTED RETURN OF STOPCOCK FOR EVALUATION. FACILITY WILL HOLD THE STOPCOCK FOR 30 DAYS BEFORE RETURNING TO COVIDIEN FOR FAILURE ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN THAT THE STOPCOCK HAD A LEAK THROUGH THE VALVE. REPORTER REPORTED "THIS LEAK COULD INTRODUCE AIR/LIQUID TO THE CIRCULATORY SYSTEM." REPORTER IS NOT AWARE OF ANY PT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT THREE WAY STOPCOCK | STOPCOCK | FMG | COVIDIEN/FORMERLY TYCO HEALTHCARE | 8018374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |