RETROGUARD ARTERIAL SAFETY VALVE

Additional Manufacturer Narrative

THE VALVE IS SOLD BULK, NON-STERILE TO THE CUSTOMER FOR FURTHER PROCESSING INTO FINAL STERILE PACKS. DEVICE EVALUATION COULD NOT BE CONDUCTED AS THE COMPLAINT SAMPLE WAS NOT RETURNED. A DHR REVIEW WAS CONDUCTED AND SHOWED NO MANUFACTURING ANOMALIES RELATED TO THE REPORTED COMPLAINT CONDITION. THE ROOT CAUSE OF THE ALLEGED ISSUE IS UNKNOWN.

Description of Event or Problem

A REPORT RECEIVED FROM A CUSTOMER STATES THAT THE VALVE LEAKED DURING USE AND HAD TO BE CUT FROM THE CIRCUIT. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. 10UNITS OF DEVICES FROM ANOTHER LOT WERE EVALUATED. TO DEMONSTRATE THE SCENARIO, THE DEVICES WERE CONNECTED TO A ROTARY PUMP AND SUBJECTED TO A FORWARD FLOW OF 1.0 L/MIN. DURING THE PROCESS, A HEMOSTAT WAS USED TO REPLICATE THE CRACK BY SUBJECTING THE VALVE TO BLUNT FORCE UNTIL THE AIR BUBBLES DISAPPEAR. 3 OUT OF THE 10 VALVES GENERATED THE CRACK SIMILAR TO THE ONE SEEN IN THE PICTURE SENT BY THE CUSTOMER. SUBJECTING THE VALVE TO BLUNT FORCE CAN CAUSE CRACKS TO GENERATE ON THE WELD LINE. AS A PROACTIVE MEASURE, THE MELT TEMPERATURE FOR THE VALVES MOLDING PROCESS WILL BE INCREASED TO 517°F TO MINIMIZE ANY CRACKS DEVELOPING FROM APPLICATION OF HEMOSTATS BY USERS.