This report has been identified as b.Braun medical inc.Internal report # (b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility did return a photo of the involved catheter.Based on the photo, the catheter tip appeared to be fractured and missing.However, no specific conclusions can be drawn from the photo.Without the actual used sample, a thorough sample analysis could not be performed.While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through needle due to possible danger of shearing." 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.All available information has been forwarded to the device manufacturer of the catheter.If additional pertinent information becomes available, a follow-up report will be filed.
|