MalfunctionMJJ
RETROGUARD ARTERIAL SAFETY VALVE
Received Dec 27, 2018
Report 1649914-2018-00100 · MDR key 8200216
Device
Generic name
Cpb Check Valve
Manufacturer
Quest Medical, IncModel number
4007100Catalog number
4007100
Lot number
0560968E06
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE ALLEGED INCIDENT OCCURRED OUTSIDE OF THE US. THIS MEDWATCH IS BEING SUBMITTED BECAUSE QUEST DISTRIBUTES A SIMILAR DEVICE IN THE US. AN INVESTIGATION WILL BE CONDUCTED ON THE COMPLAINT SAMPLES AND A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WITH THE VALVE. THE REPORT STATES THAT PARTICULATE MATTER WAS FOUND IN THE HOUSING OF THE VALVE DURING CIRCUIT ASSEMBLY. THE DEVICE WAS NOT USED ON A PATIENT.