Investigation summary: four photos were returned for investigation.A burred catheter was observed in the returned photos.One actual sample in opened packaging was returned for investigation.The sample was subjected to visual inspection.Burred catheter and v-cut was observed on the returned sample.The nonconformance sample was challenged at the automated vision inspection system.The system was able to reject the nonconformance and the sample was sent into the reject bin.The v-cut and burr could have been caused by cannula pierced through catheter.The cannula pierced through catheter occurred during assembly of catheter and cannula or during product application when the product was manipulated.However, there is an automated vision inspection machine, which can detect and reject product with cannula pierced through catheter in the assembly process.Hence, the root cause of the nonconformance could not be determined.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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