This report has been identified as b.Braun medical internal report number (b)(4).A tubing set and a photograph were provided for evaluation.All information associated with this event was submitted to the bloodline manufacturer.According to the investigation, the tubing set and photo were both visually inspected with a black mark being observed on the tubing near the venous chamber, confirming the reported issue.Photographs were provided to manufacturing for review.Manufacturing was unable to determine the root cause of this issue based on the available information.All products are released meeting quality criteria and manufacturing specifications.A search of the complaint database for the blood tubing set lot numbers 10554024 and 10554025 showed no additional complaints of a similar nature as of complaint closure, indicating this is an isolated occurrence.10554025 showed no additional complaints of a similar nature as of complaint closure, indicating this is an isolated occurrence.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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