Additional Manufacturer Narrative · 1
RESULTS - (OTHER): SMITHS MED INT'L LTD STATES THAT THE INVESTIGATION WAS LIMITED AS NO SAMPLES WERE RETURNED FOR ANALYSIS. INVESTIGATION WAS, THEREFORE, LIMITED TO THE FOLLOWING SOURCES OF INFO: THE PRODUCT INSTRUCTION FOR USE LEAFLET. THE COMPLAINT INCIDENT REPORT FORM. COMPLAINTS HISTORY FOR THIS PRODUCT. A REVIEW OF THE COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT ON THE POSSIBLE TWO REPORTED LOT NUMBERS. THOUGH, THERE HAVE BEEN OTHER REPORTS FOR CUFF DEFLATION ON THIS PRODUCT CODE IN THE PAST FIVE YEARS, THESE ARE HISTORICAL AND DOES NOT INDICATE A SYSTEMATIC FAILURE DURING MFR, ESPECIALLY WHEN COMPARED WITH SALES OF PRODUCTS ANNUALLY. A FURTHER REVIEW OF MFG RECORDS CONFIRMED THE PRESENCE OF A 12 HOUR INFLATION CHECK CARRIED OUT ON 100% OF THIS LINE. ROOT CAUSE: IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT. IT IS STATED THAT THE PRODUCT WAS NOT TESTED PRIOR TO USE IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS AND WAS DISCARDED FOLLOWING REMOVAL. AS SUCH, WE ARE UNABLE TO HYPOTHESIZE WHAT CAUSED THE PRODUCT TO DEFLATION. THIS REPORT HAS BEEN LOGGED FOR TRENDING.