This report has been identified as b.Braun medical internal report number (b)(4).One unopened sample and one photo were provided for evaluation.Visual evaluation of the needle showed no damage or any liquid on the 27 ga needle or any other component in the tray.The photo showed a used 27 ga needle, with what appears to be a drop of some type of liquid/substance below the hub on the needle.There are also drops of liquid observed on the csr wrap from the kit.Based on the evaluation results, the returned sample did not confirm the reported defect.However, the photo did confirm some unknown droplet on the needle.Although the photo did confirm a drop of an unknown substance, it does not offer the details necessary to determine a root cause at this time.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.
|