RETROGUARD ARTERIAL SAFETY VALVE
Received Jul 12, 2019 · Event occurred Jun 19, 2019
Report 1649914-2019-00032 · MDR key 8787006
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
QUEST MEDICAL SELLS THIS DEVICE BULK NON-STERILE TO OEMS WHO CARRY FURTHER PROCESSING ON THE DEVICE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION AND NO LOT NUMBER WAS PROVIDED. DEVICE EVALUATION AND DHR REVIEW COULD THEREFORE NOT BE COMPLETED. LEAK TESTING IS CONDUCTED AS PART OF THE MANUFACTURING PROCESS FOR THIS DEVICE. ANY LEAKAGE FROM THE DEVICE WOULD HAVE BEEN IDENTIFIED DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE UNDERGOES PRIMING BEFORE USE. THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION IS UNKNOWN.
Description of Event or Problem
A REPORT WAS RECEIVED REGARDING AN ALLEGED INCIDENT RESULTING FROM THE VALVE. THE REPORT STATES THAT 30-45 MINUTES AFTER ATTACHING THE RG ON THE PUMP, THERE WAS A PUDDLE EVERYWHERE. THE ALLEGED ISSUE DID NOT RESULT IN ANY PATIENT COMPLICATIONS.