Visual examination of the returned devices confirmed that the blister trays had various degrees of damage to the blister trays and creases in the tyvek lids.Five of the six units had an open seal.All six units showed evidence that the blister packs had been completely sealed at one point.Based upon the visual examination, it appears that the damaged product is related to an environmental/handling event that occurred sometime after distribution by bard.A review of the manufacturing records for the reported product code and lot number revealed that there were no discrepancies during manufacture and there was no evidence of any manufacturing related issue which would cause or contribute to the reported event.The damage that occurred to the blister lid is a clear breach of the sterile barrier; however, this damage is highly evident to the user.
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