As reported by the user facility: event 1: per conversation, three (3) occurrences of contiplex echo catheter breakage.For two (2) of the occurrences, the catheter needed to be removed surgically.For the third occurrence, the catheter was removed at the bedside.The breakages occurred during insertion or were noted at the time of removal.
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This report has been identified as event 1 of b.Braun medical internal report number (b)(4).Two (2) photos were provided for evaluation.The two photos depicted a used catheter that had been broken toward the tip.When investigated further, it was determined that this breakage could not have been due to any manufacturing problem, and thatt the damage is due to improper application technique.Review of the discrepancy management system (dsms) database and a review of the batch history records was unable to be performed, as no lot number was provided.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.
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