Procedure: left humerus fracture repair.Cathplace: interscalene nerve block.Please reference: 2026095-2014-00253/14-00992.Report 1 of 2: tray 1.A nurse reported that a catheter broke into two pieces during use, by an anesthesiologist, on a patient during a nerve block.After removing the stylet and needle, the anesthesiologist gently pulled back the catheter.At this point, the catheter broken into two pieces at the insertion point near the skin.The anesthesiologist was able to remove the catheter pieces and the device was reported as discarded.It is unknown which catheter was used from which model number t-bloc tray, therefore both model numbers are being investigated by (b)(4).No injury or medical intervention was reported.
|
Method: the device will not be returned for an analysis.The lot number was received and a review of the device history record (dhr) and process evaluation were conducted.Results: as the device was not available for an evaluation, testing results cannot be obtained.Per the dhr review the lot met manufacturing specification at release.The process review was performed and the lot was manufactured according to approved procedures.The process evaluation performed indicated no root cause was identified for the function and damage to catheter as the assessment did not find any activity in the incoming inspection and manufacturing process that could have led to affect the integrity of the components inside the tray.Conclusions: the device was not returned to halyard for an evaluation, therefore we are unable to determine a cause for the reported event.If additional information pertinent to this complaint or the sample is received, (b)(4) will submit a follow-up report.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.
|