Additional Manufacturer Narrative · 1
RESULTS EVALUATION: INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. THE SOURCE OF THE LEAKAGE WAS IDENTIFIED AS A TEAR OF 2.1 MM, 14.5 MM FROM THE DISTAL TIP OF THE TUBE. 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 CUFF DEFLATION IN USE, ON THIS PRODUCT CODE DURING THE PAST FIVE YEARS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR, ESPECIALLY WHEN COMPARED WITH SALES OF LARGE VOLUME ANNUALLY. A FURTHER REVIEW OF MANUFACTURING 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 INFLATION 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 ANATOMY CAN BE EXPERIENCED. THIS REPORT HAS BEEN LOGGED FOR TRENDING.