The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an damaged infusion set is confirmed but the exact cause remains unknown.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The needle cover was present over the needle.The safety mechanism was loose and partially advanced.The orange component was not present in the safety mechanism and was not returned.No apparent evidence of mechanical damage was noted on device.The condition of the device prior to package opening is unknown.Based on the returned sample, possible contributing factors include excessive manipulation or damage during handling leading to dislodgement of the safety mechanism component from the device.Since the safety mechanism was found to be damaged, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of asdws0136 showed no other similar product complaint(s) from this lot number.
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