This report has been identified as b.Braun medical internal report number (b)(4).Multiple attempts were made to contact the initial reporter and end customer for additional information.At this time, no additional information or sample were provided for evaluation.Based on the data reported, b.Braun is unable to determine the root cause of the reported incident.There is currently no indication that a malfunction occurred which caused or contributed to the incident.Out of an abundance of caution, this event is being reported as an adverse event.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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