RETROGUARD ARTERIAL SAFETY VALVE
Received Feb 24, 2018
Report 1649914-2018-00023 · MDR key 7294368
Device
Product problems
- Crack
- Crack
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE WAS EVALUATED AND A LONGITUDINAL CRACK WAS SEEN ON THE HOUSING OF THE VALVE. THE NATURE OF THE CRACK SUGGESTS THAT THE CRACK MAY HAVE RESULTED FROM A BLUNT FORCE IMPACT ON THE DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE INVOLVES A 100% VISUAL AND FUNCTIONAL INSPECTION. EACH DEVICE IS ALSO FUNCTIONALLY TESTED FOR LEAK, FORWARD FLOW AND RETROGRADE FLOW. NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER TO ENABLE A DHR REVIEW. HOWEVER, A 24 MONTHS COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE PART NUMBER AND NO SIMILAR COMPLAINT WAS IDENTIFIED. THIS COMPLAINT IS AN ISOLATED INCIDENT AND THE ROOT CAUSE IS UNKNOWN.
Description of Event or Problem
A REPORT RECEIVED FROM A CUSTOMER STATES THAT A CRACK WAS SEEN ON THE RETROGUARD VALVE DURING PRIME. THE ALLEGED ISSUE DID NOT RESULT IN ANY PATIENT COMPLICATIONS.