FDA Adverse Event
Malfunction
Summary report: N
AORTIC PERFUSION CANNULA
MDR report key: 46306
·
Received November 1, 1996
Report
- Report Number
- 1713910-1996-00027
- Event Type
- Malfunction
- Date Received
- November 1, 1996
- Date of Event
- September 12, 1996
- Report Date
- November 1, 1996
- Manufacturer
- RESEARCH MEDICAL, INC.
- Product Code
- DWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PRIOR TO USE THE MD INSERTED A HOSP DESIGNED OBTURATOR INTO THE CANNULA. THE CONNECTOR CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC PERFUSION CANNULA | PERFUSION CANNULA | DWF | RESEARCH MEDICAL, INC. | NA | 87396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |