FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ CATHETER
MDR report key: 1021573
·
Received March 24, 2008
Report
- Report Number
- 6000002-2008-06322
- Event Type
- Malfunction
- Date Received
- March 24, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER HAD BROKE AND BLOOD LEAKED BACKED INTO THE THERMISTOR CONNECTOR. MODEL NUMBER UNK; HOWEVER, THE NURSE INDICATED THAT IT WAS A SWAN-GANZ CATHETER. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ CATHETER | UNKNOWN | DYG | EDWARDS LIFESCIENCES, PR | CCUNKNOWN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |