This report has been identified as b.Braun medical internal report number (b)(4).One (1) photo of two (2) sets was returned for evaluation.Visual inspection was performed, and it was noted that the bonded tubing is damaged on both pictured sets.A one year historical review was performed against the reported item and it was noted that this is the only occurrence reported.In addition, a 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 investigation, the exact root cause of the reported defect could not be determined at this time.If additional pertinent information becomes available a follow-up report will be filed.
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