Four cleo® 90 infusion sets were returned for analysis in used conditions.Visual inspection revealed that the retractor was active and the base was missing.Relevant document were reviewed and deemed adequate.A review of manufacturing process was performed.Line clearance record, inserter assembly operation, training records, maintenance records of site threader were all reviewed; no discrepancies noted.Three samples from the production line was inspected and given the worse test cases.No detachment was detected.Based on the evidence no root cause was determined as the complaint was not confirmed.
|