FDA Adverse Event
Malfunction
Summary report: N
RETROGUARD ARTERIAL SAFETY VALVE
MDR report key: 717930
·
Received October 11, 2006
Report
- Report Number
- 1649914-2006-00046
- Event Type
- Malfunction
- Date Received
- October 11, 2006
- Date of Event
- April 4, 2006
- Report Date
- May 4, 2006
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- MJJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A CRACK WAS NOTICED ON THE HOUSING: HOWEVER, THE DEVICE WAS TESTED AND PASSED OUR PRESSURE DECAY TEST THAT IS PERFORMED DURING NORMAL MFG. THIS CONCLUDES THAT THE CRACK DOES NOT AFFECT FUNCTIONALITY NOR WILL IT CAUSE ANY LEAKING. THIS COMPLAINT CONDITION IS CONSIDERED TO BE A COSMETIC DEFECT.
Description of Event or Problem · 1
THE CUSTOMER RETURNED A VALVE AND A NOTE TO A QUEST SALES REP AT THE AMSECT SHOW. THE PRODUCT WAS A RETROGUARD, PRODUCT CODE 4007200. THE DEVICE HAD A CRACK. THIS IS THE ONLY INFO PROVIDED TO QUEST. PRODUCT CODE 4007200, LOT 25304.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RETROGUARD ARTERIAL SAFETY VALVE | FLOW CHECK VALVE | MJJ | QUEST MEDICAL, INC. | 4007200 | 25304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |