Additional Manufacturer Narrative · 1
INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. THE SOURCE OF THE LEAKAGE WAS LOCATED IN THE PILOT BALLOON, APPROX 32MM AWAY FROM THE CONNECTOR. THE SOURCE OF THE LEAKAGE WAS EXAMINED UNDER MAGNIFICATION AND FOUND A TEAR, APPROX 2.2MM IN LENGTH. A REVIEW OF OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR THE TWO POSSIBLE LOT NUMBERS IDENTIFIED. THOUGH THERE HAVE BEEN COMPLAINTS FOR LEAKAGE IN USE, ON THIS PRODUCT CODE DURING THE PAST FIVE YEARS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR. A FURTHER REVIEW OF THE MFG RECORDS CONFIRMED THE PRESENCE OF AN INFLATION CHECK CARRIED OUT ON 100% OF THIS PRODUCT LINE. ROOT CAUSE: IT IS STATED THAT THE PRODUCT WAS TESTED PRIOR TO USE AND ONLY BECAME DEFLATED ONE DAY FOLLOWING INSERTION. AS SUCH, THIS INCIDENT IS UNLIKELY THE RESULT OF AN ASSEMBLY FAULT. WE FEEL THE MOST LIKELY CAUSE FOR THIS INCIDENT IS THAT THE CUFF BECAME DAMAGED FOLLOWING INFALTION OF THE PRODUCT CUFF, RESULTING IN THE CUFF DEFLATION. THOUGH THESE PRODUCTS ARE DESIGNED TO BE AS ROBUST AS FUNCTIONALLY POSSIBLE, DEFLATION OF THE PRODUCT CUFF ON THE PT ANATOMAY CAN BE EXPERIENCED. THIS REPORT HAS BEEN LOGGED FOR TRENDING.