FDA Adverse Event
Malfunction
Summary report: N
AORTIC PERFUSION CANNULA
MDR report key: 44351
·
Received October 8, 1996
Report
- Report Number
- 1713910-1996-00028
- Event Type
- Malfunction
- Date Received
- October 8, 1996
- Date of Event
- September 12, 1996
- Report Date
- October 8, 1996
- Manufacturer
- RESEARCH MEDICAL INC.
- Product Code
- DQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FOLLOWING CANNULATION IT WAS DISCOVERED THE CONNECTOR HAD CRACKED. THE M.D. USED A HOSP DESIGNED OBTURATOR FOR INSERTION OF THE CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC PERFUSION CANNULA | PERFUSION CANNULA | DQR | RESEARCH MEDICAL INC. | NA | 87396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |