The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga power glide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned.The catheter advancement wings were detached from the assembly, and the safety mechanism outer housing was still attached to the wings.The remainder of the safety mechanism was not returned for evaluation.Microscopic inspection of the safety mechanism housing revealed it to appear properly formed.Stress fracturing was observed near one of the securement features.While the safety mechanism was observed to have become detached from the needle shaft, inspection of the returned safety housing was insufficient to identify the cause of that detachment, and the remaining safety mechanism components were not returned for evaluation.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of redn3382 showed no other similar product complaint(s) from this lot number.
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