RETROGUARD ARTERIAL SAFETY VALVE

Additional Manufacturer Narrative

THERE WAS NO REPORTED PATIENT COMPLICATION RESULTING FROM THE ALLEGED ISSUE. THE DEVICE WILL BE INVESTIGATION AND A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A CUSTOMER REPORTED AN ISSUE WITH THE VALVE. THE REPORT STATES THAT DURING A CIRCUIT ASSEMBLING AN OPERATOR FOUND FOREIGN MATTER COLORED IN BLACK IN THE RETROGUARD HOUSING. THE OPERATOR ELECTED NOT TO USE THE VALVE FOR THE CIRCUIT.

Additional Manufacturer Narrative

THE DEVICE WAS INSPECTED AND PRESENCE OF PARTICULATE MATTER WAS CONFIRMED. QUEST MEDICAL HAS IMPLEMENTED SEVERAL CONTROLS TO PREVENT THIS ISSUE INCLUDING MAINTENANCE OF AN ISO CLASS 8 MANUFACTURING ENVIRONMENT, EMPLOYEE GOWNING AND UNIFORM PROCEDURES, ROUTINE CLEANING, BATCH TO BATCH LINE CLEARANCE ACTIVITIES AND MANUFACTURING SURFACE CLEANING. PARTICULATE COUNT, TEMPERATURE AND HUMIDITY IN THE CLEAN ROOM IS CONSTANTLY MONITORED IN ACCORDANCE WITH INTERNAL ENVIRONMENTAL MONITORING PROCEDURES. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. AS A PROACTIVE MEASURE, QUEST MEDICAL HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE. NO FURTHER SUPPLEMENTS WILL BE SUBMITTED UNLESS NEW SIGNIFICANT FINDINGS EMERGE.