Exemption number e2016018.B.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned, however a photo was provided for evaluation.This product is subjected to a 100% inspection by an in-line vision system that is calibrated and subjected to regular verifications to ensure it is functioning properly.The defect observed in the provided photo would have been detected and rejected by the in-line vision system.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the device history record 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.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional pertinent information becomes available a follow-up report will be filed.
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