Aspen surgical received a report from the distributor that product was found with seal issues.The actual device was returned for evaluation.The manufacturing lot number was provided for review as well.The return of the sample confirmed the issue identified from the distributor.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.Upon review of the samples, the seals on the film show incomplete transfer of adhesive.This incomplete seal can be caused by unexpected process interruptions identified in operating instructions.Additionally, according to the manufacturing process, these parts are manually loaded into recessed pockets on a packaging machine per specified work instructions.If incorrectly loaded or not orientated properly, this will cause an incomplete seal.Therefore a likely root cause for the seal issue may be attributed to an operator error.The pouch label, identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Additionally, production supervisors and operation were notified of this issue during the daily update meetings.Based on this information, no further action is required.
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