This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was provided for evaluation.The sample was spiked into an iv container and allowed to run via gravity.During this functional testing, it was noted that the sample was found to be leaking from the air eliminating filter vent.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.Based on the data from our evaluation, the exact nature of the reported defect could not be determined at this time.If additional pertinent information becomes available, a follow-up will be submitted.
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