Additional Manufacturer Narrative · 1
RESULTS EVALUATIONS (OTHER): INVESTIGATION: THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND THE REPORT OF LEAKAGE WAS CONFIRMED. THE CUFF WAS INFLATED AND LEAKAGE STARTED IMMEDIATELY AFTER AIR INFUSION. IT WAS ALSO FOUND THE CUFF WAS PARTIALLY STICKING TO THE TUBE UPON INFLATION. THE STICKING PORTION SEPARATED SOON. THE LEAKAGE PORTION WAS LOCATED IN THE CUFF, APPROX .18MM AWAY FROM THE TUBE END. THE LEAKAGE PORTION WAS EXAMINED UNDER MAGNIFICATION AND A TEAR WAS FOUND, APPROX 1.25M IN LENGTH. A REVIEW OR OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR THE LOT NUMBER IDENTIFIED. THOUGH THERE HAVE BEEN COMPLAINTS FOR CUFF DEFLATION IN USE, ON THIS PRODUCT CODE DURING THE PAST FIVE YRS, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF AN INFLATION CHECK CARRIED OUT ON 100% OF THIS PRODUCT LINE PRIOR TO PACKAGING. ROOT CAUSE: IT IS STATED THAT THE UNIT WAS TESTED PRIOR TO USE AND ONLY BECAME DEFLATED 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 PILOT LINE BECAME DAMAGED FOLLOWING INFLATION OF THE PRODUCT CUFF, RESULTING IN THE CUFF DEFLATION. THIS REPORT HAS BEEN LOGGED FOR TRENDING.