Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was 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 samples 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.Customer provided samples for evaluation confirming components in the seal.During the production of this lot, the most likely event is the patient label dropped from the pick and place system.Type of fluttering components can occur when the machine is suddenly stopped or when the machine inadvertently dispenses extra components.The root cause for this event is machine issue.Production supervisors were notified of the event.Based on this information, no further action is required.
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