The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged ''powerglide'' pro assembly was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a portion of ''powerglide'' midline catheter assembly.The visible portion of the device included the distal end of the needle and catheter.The catheter overlaid the needle.The guidewire protruded from the needle.A kink was visible in the guidewire near the exit site form the needle.The distal end of the guidewire was not visible in the photograph.While guidewire damage was evident in the submitted photograph, inspection of the image was insufficient to identify the root cause of that damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted guidewire advancement into issue and device manipulation.A lot history review (lhr) of recw1304 showed no other similar product complaint(s) from this lot number.
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