Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY DEPLOYING MULTIPLE TEFLON INFUSION SETS WHEN UNWINDING TUBING AND REMOVING ADHESIVE LINERS, RESULTING IN TWO INFUSION SETS DISENGAGING FROM THEIR APPLICATORS BEFORE INSERTION, WHILE A THIRD SET WAS SUCCESSFULLY INSERTED; THE AFFECTED LOT WAS 6011007, AND NO ALARMS OCCURRED, WITH TROUBLESHOOTING AND EDUCATION PROVIDED REGARDING CORRECT INFUSION SET HANDLING AND INSERTION. NO REPORTED INJURY OR ADVERSE PHYSIOLOGICAL EFFECTS. OUTCOMES INCLUDED NO CLINICAL IMPACT, NO EMERGENCY TREATMENT, AND NO HOSPITALIZATION. INVESTIGATION INCLUDED CUSTOMER INTERVIEW AND REVIEW OF USE PROCEDURES TO ASSESS HANDLING, INSERTION TECHNIQUE, AND PRODUCT LOT INFORMATION. INVESTIGATION OF THIS CASE REVEALED USE-RELATED HANDLING ISSUES CONSISTENT WITH PREMATURE APPLICATOR DISENGAGEMENT DURING TUBING UNWINDING AND ADHESIVE LINER REMOVAL, WITHOUT EVIDENCE OF DEVICE MALFUNCTION OR CONNECTIVITY FAILURE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER TECHNIQUE DURING PREPARATION AND DEPLOYMENT OF THE INFUSION SET.