Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Seven (7) unopened samples were returned for evaluation.The samples were visually inspected and no shearing, damage or any manufacturing defect was able to be observed.In addition physical testing of the catheters was performed to try and replicate/simulate the reported defect.No shearing or breakage was able to be replicated or confirmed.In addition, the house retain samples of the reported lot were visually inspected per specification with passing results.A review of the batch history records was performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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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