FLEXIBLE TIP WITH SLIMLINE RETENTION

Description of Event or Problem

CUSTOMER REPORTS ENEMA TIP SEPARATED FROM THE CLEAR PLASTIC ADAPTER THAT ATTACHES TO THE BAG AND ENTERED THE PATIENT'S BODY DURING A PROCEDURE. PATIENT WAS A MALE. COMPLAINANT INSPECTED OTHER TIPS IN THE BOX AND FOUND AT LEAST ONE OTHER WHERE THE TIP WERE NOT SECURELY FASTENED TO THE ADAPTER. IT SLIDES OUT AS IF THE ADAPTER WAS TOO SMALL OR THERE WAS NO GLUE ON IT (NOT SNUG). TWO CASES WILL BE RETURNED FOR INVESTIGATION. THE USED TIPS WERE DISCARDED.

Additional Manufacturer Narrative

ROOT CAUSE: THIS DEFECT IS AN OPERATIONAL ERROR DUE THAT THE GLUE IS APPLIED TO THE TIP AND ADAPTER MANUALLY. CONCLUSIONS: DEVICE HISTORY RECORD WAS REVIEWED FINDING NO DEFECTS DETECTED IN THE INSPECTION OF THIS LOT. TWENTY ONE SAMPLES WERE RECEIVED FROM LOT NUMBER 3202055 OF MODEL NUMBER 119042. ALL SAMPLES WERE EVALUATED UNDER PROCEDURE FOR TENSILE STRENGTH AND IN FACT, IN ONE OF THE SAMPLES, THE PLASTIC ADAPTER GETS LOOSE. THEREFORE THIS COMPLAINT WAS CONFIRMED. CORRECTIVE ACTIONS: A NOTIFICATION REPORT IS BEING ISSUED TO INFORM ALL PERSONNEL WITHIN THE ENEMA TIPS ASSEMBLY PROCESS ABOUT THIS PROBLEM. OUR PRODUCTION PROCESS IS BEING CHECKED PUTTING SPECIAL ATTENTION ON THIS ISSUE. WITH THE REFERENCE REPORTED, NOTIFICATION WAS PROVIDED TO APPROPRIATE MANUFACTURING AND QUALITY ASSURANCE PERSONNEL.