Event 3: this report has been identified as b.Braun medical internal report number (b)(4).Six samples were sent back for evaluation 3 unopened original packages, 2 un-contaminated without packaging, and 1 sample in an opened package.Two pictures have been provided for this investigation.Two pictures received were visually evaluated per specification for foreign material nonfluid path, it was noted inside the syringe a ring of substance.All six samples were visually evaluated per specification, one sample presented the ring of silicone inside the syringe.5 samples passed visual inspection.Incidents of this nature are attributed to operator oversight during the inspection process of the product for excess silicone.Although our training procedures ensure that all employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.An approved project is in place to address issues of this nature.Retained units were evaluated and passed the internal testing.A 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.Additionally, 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.
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