This report has been identified as b.Braun medical internal report number (b)(4).Event 5.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.The complaint sample was shown to have been delivered to the manufacturing site; however, it was determined that the sample had either been discarded or misplaced before a thorough investigation could take place.The investigation was carried out with the information provided without the sample.In the event the sample is found, we will reopen the investigation for technical analysis.Through visual examination of two (2) photos, a cut/hole was observed on the tubing of the blood sets.The sample within the photo is not within specification; the reported defect is confirmed from the photos.While a defect was confirmed, the exact root cause could not be determined.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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