FDA Adverse Event
Malfunction
Summary report: N
DUAL DRAINAGE VENOUS RETURN CANNULA
MDR report key: 110694
·
Received August 1, 1997
Report
- Report Number
- 1713910-1997-00027
- Event Type
- Malfunction
- Date Received
- August 1, 1997
- Date of Event
- June 14, 1997
- Report Date
- July 31, 1997
- 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
DURING USE OF A VENOUS RETURN CANNULA A SPLIT/CRACK WAS NOTED IN THE CANNULA. THE CANNULA WAS REPLACED WITH NO ADVERSE AFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL DRAINAGE VENOUS RETURN CANNULA | VENOUS RETURN CANNULA | DWF | RESEARCH MEDICAL, INC. | NA | 89938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |