This report has been identified as b.Braun medical internal report number (b)(4).Several samples were provided for evaluation.The sets were visually evaluated with no defect observed.Based on the evaluation results, the reported defect was not confirmed.Although the reported defect was not confirmed, it is possible that the defect was due to lack of solvent.Due to issues of this nature an assembly technique procedure was created to specify the correct solvent application.All personnel involved in the manufacturing process have been trained to the assembly technique to prevent recurrence.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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