This report has been identified as b.Braun medical inc.Internal report # (b)(4).One used catheter fragment, without packaging, was received for evaluation.The catheter appeared stretched and fractured at the tip end, with the inner coil unwound and extending out at the point of fracture.Stretching was also observed on the catheter tube at the area of the fracture.The damage observed on the catheter appears consistent with catheters in which a section is pulled beyond its design capabilities.The reporting facility indicated the catheter broke outside of the patient.It is possible the catheter may have become caught on something at the patient's bedside, which stretched the catheter to the point of fracture.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.
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