FDA Adverse Event
Malfunction
Summary report: N
RETROGUARD ARTERIAL SAFETY VALVE
MDR report key: 879258
·
Received September 19, 2006
Report
- Report Number
- 1649914-2006-00096
- Event Type
- Malfunction
- Date Received
- September 19, 2006
- Report Date
- September 15, 2006
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- MJJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEIR END CUSTOMER REPORTED TWO INSTANCES IN WHICH THE DEVICE WAS CRACKED AND LEAKED. THE SAMPLES WERE SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200; LOT NUMBER 26850.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RETROGUARD ARTERIAL SAFETY VALVE | FLOW CHECK VALVE | MJJ | QUEST MEDICAL, INC. | 4007200 | 26850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |