This report has been identified as b.Braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for this product type.If additional pertinent information becomes available, a follow-up report will be filed.
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