Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was not returned for evaluation.Photographic evidence along with the manufacturing lot number were provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the photos confirmed the issue from the distributor.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.According to the manufacturing process, these parts are loaded into recessed pockets on a packaging machine per specified work instructions.If incorrectly loaded or not orientated properly, the product interferes with the sealing process.This can occur during startup or troubleshooting, in which case it is the operator responsibility to review the line and clear it of any discrepancies.Therefore, the likely root cause is attributed to operator error.Production supervisors and operations were notified of this issue.Based on this information, no further action is required.
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