This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample was returned for evaluation.A visual evaluation was performed, and it was noted when looking under a microscope a brownish embedded particulate was observed on the outside of the y-port.Based on the evaluation results, the defect reported was not confirmed.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.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.
|