Event 5: this report has been identified as b.Braun medical internal report number (b)(4).All available information associated with this event was submitted to the bloodline manufacturer for further evaluation.According to the investigation results, seven unopened cases and one opened case of ten blood tubing sets were provided for evaluation.The samples were visually and physically tested, and no defects were observed.The reported defect was unable to be confirmed.A review of manufacturing records for sl-2010m2096 lot 20354006 was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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.Correction - during submission of the initial report the medical device problem code was submitted incorrectly, the correct code is 1504 - material puncture/hole.
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