FDA Adverse Event
Injury
Summary report: N
DUAL STAGE VENOUS RETURN CANNULA
MDR report key: 189634
·
Received September 25, 1998
Report
- Report Number
- 1649139-1998-00001
- Event Type
- Injury
- Date Received
- September 25, 1998
- Date of Event
- August 25, 1998
- Report Date
- September 25, 1998
- Manufacturer
- CHASE MEDICAL
- Product Code
- DWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A FACSIMILE REPORT WAS SENT TO CHASE MEDICAL BY THE CHASE MEDICAL DISTRIBUTOR IN SINGAPORE ON 8/27/98 INDICATING THAT DURING USE A DUAL STAGE VENOUS RETURN CANNULA (PRODUCT CODE DWF-3651S) SEPARATED INTO TWO PIECES AT A LOCAL HOSP ON AUGUST 25, 1998. THE CANNULA PERFORMED PER ITS INTENDED USE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PT WAS DISCHARGED FROM THE HOSP FOLLOWING RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL STAGE VENOUS RETURN CANNULA | DUAL STAGE VENOUS RETURN CANNULA | DWF | CHASE MEDICAL | DWF-3651S | 9806071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |