This report has been identified as b.Braun medical inc.Internal report # (b)(4).A total of two (2) unused, unopened samples, in packaging indicating the reported lot number 0061376564, were returned for evaluation.Upon visual observation: sample # 1 -- two small tears/puncture marks were observed in the white tyvek backing of the pouch.The tears corresponded with each end of the enclosed syringe.Sample # 2 -- one small tear/puncture mark was observed in the white tyvek backing of the pouch.The tear corresponded with the plunger end of the enclosed syringe.Based on the results of this investigation, it could not be definitively determined where in the packaging/shipping/handling process this issue occurred.While no specific conclusions could be drawn, it should be noted that although our packaging is tested to astm standards during development to ensure that they will maintain integrity under normal to strenuous shipping conditions, excessive handling may result in some damage.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.
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