Rep reported that the unitized distal catheter came off of the valve intraoperatively.They had to tie it with a silk tie.No delay in surgery.No adverse consequences.We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.Please refer to complaint (b)(4).An initial is being generated to submit an mdr reclassifying the incident as a malfunction.
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