This report has been identified as b.Braun medical internal report number (b)(4).One used and multiple unused samples were provided for evaluated.Based on the evaluation results, red substance was observed inside the cannula hub of the used sample.However, the manufacturer evaluated their production processes and were unable to identify a process that would create this defect.The unused samples were also evaluated, and no defects were observed.Review of the batch history records was also 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.
|