Additional Manufacturer Narrative · 1
INVESTIGATION: SMITHS MEDICAL INTERNATIONAL'S INVESTIGATION STATED THAT THE EVENT SAMPLE WAS RETURNED, AND IT WAS CONFIRMED THAT THE INFLATION LINE WAS DETACHED. A REVIEW OF OUR COMPLAINTS HISTORY CONFIRMED THIS TO BE THE FIRST COMPLAINT FOR THE TWO POSSIBLE PRODUCT LOT NUMBERS GIVEN, AND THE FIRST COMPLAINT OF THIS NATURE FOR THIS PRODUCT CODE. A TECHNICAL DOCUMENTATION REVIEW WAS PERFORMED WHICH RAISED NO ANOMALIES. ROOT CAUSE: WE ARE UNABLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THIS INCIDENT, HOWEVER, WE HAVE DETERMINED THE POTENTIAL ROOT CAUSE TO BE EITHER, OR A COMBINATION OF THE FOLLOWING: EXCESSIVE FORCE - IT IS POSSIBLE FOR A SHARP PULL TO DISLODGE THE INFLATION LINE DURING USE. THERE IS EVIDENCE OF SOLVENT APPLICATION ON THE INFLATION LINE. INSUFFICIENT SOLVENT APPLIED DURING ASSEMBLY COULD HAVE RESULTED IN THE INFLATION LINE BECOMING DETACHED DURING USE. IT IS NOTED THAT THE DEVICE REMAINED FUNCTIONAL FOR 21 DAYS PRIOR TO THE DETACHMENT. IN LIGHT OF THIS WE FEEL THE MOST LIKELY ROOT CAUSE IS THAT THE INFLATION LINE WAS PUT UNDER TENSION, RESULTING IN THE DETACHMENT. CORRECTIVE ACTION: IN VIEW OF THIS BEING THE FIRST INCIDENT FOR THIS PRODUCT CODE THIS COMPLAINT WILL BE CLOSED WITHOUT THE NEED FOR CORRECTIVE ACTIONS; HOWEVER, THIS COMPLAINT WILL BE ENTERED INTO OUR RECORDS FOR FUTURE COMPLAINTS TRENDING.