Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned 1 actual sample and 2 representative samples, observed damaged adapter outer luer thread.The damage locations were different in relative to the side of the adapter.The luer damage on the actual sample was found at the side of mold cavity number, whereas it was found at the ejector pin mark for the representative samples.As the defect was not found at the same location and not the same mold cavity number, the defect was most probably caused during the assembly process instead of the adapter molding process.The assembly process was reviewed.It was suspected that this defect was caused at the tipper.The most probable cause was the minor misalignment of the picker height between different stations in the tipper, which caused the adapter to be over-inserted during pick and place and damaged the outer luer thread.Proposed action plan: 1.Conduct complaint awareness training and communication to all insyte tipper production technicians (pts), and to monitor the occurrence of the adapter damaged outer luer thread defect.2.Retrain all insyte tipper pts on pickers height alignment in tipper procedure.Effectiveness check plan: no.Description of effectiveness check plan assigned to due date 1.After communication, interview 3 insyte tipper pts from different shifts randomly over a period of 1 month to check understanding of damaged outer luer thread defect.2.After communication and retraining, monitor 3 consecutive insyte assembled needle (an) batches for re-occurrence of damaged outer luer thread defect during in-process and outgoing inspections.(acceptance criteria = zero re-occurrence).
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