FDA Adverse Event
Malfunction
Summary report: N
AORTIC PERFUSION CANNULA
MDR report key: 36013
·
Received August 22, 1996
Report
- Report Number
- 1713910-1996-00018
- Event Type
- Malfunction
- Date Received
- August 22, 1996
- Date of Event
- July 15, 1996
- Report Date
- August 22, 1996
- Manufacturer
- RESEARCH MEDICAL INC.
- Product Code
- DWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FOLLOWING CANNULATION A CRACK IN THE 3/8" STRAIGHT CONNECTOR WAS NOTICED. THE CANNULATOR WAS REPLACED WITH NO ADVERSE EFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC PERFUSION CANNULA | PERFUSION CANNULA | DWF | RESEARCH MEDICAL INC. | NA | 85660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |