This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.The primary sterile barrier was found to have a complete seal with no damage to the lid.The secondary sterile barrier showed signs of scuff marks and indentations on the pouch.One of the shell fins pierced through the pouch, thus compromising the second sterile barrier.The damage likely occurred during transportation; however, a conclusive root cause of the damage could not be determined.Change of secondary sterile barrier to a more robust material has been implemented to account for abnormal handling and shipping.
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