This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were submitted to the manufacturer for evaluation.A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Reviewing the history records during an internal review, it was determined that the root cause of the defect is the machine; due to a high pressure of return that can be stressed and generate a perforation in the pod membrane.Based on the history records, the reported defect is confirmed.An approved project is in place to further address issues with pod internal breakthrough.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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