The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to retract guidewire is confirmed but the exact cause remains unknown.Three photo samples of an accucath device were provided for evaluation.The first photo shows the catheter with the guidewire present internally.The catheter is wrinkled and damaged forming a ¿j¿ shape.The coiled guidewire tip appears to be bending against the catheter tip.The second image shows the entire device.The catheter is still present near the housing and the needle appears to have been retracted.The third image shows the product label which indicates lot: reey2674.Based on the photo sample provided, possible contributing factors include kinking or deformation of the guidewire during insertion.The guidewire appears to have deformed around the catheter contributing to the interference during retraction.Since the reported issue was observed in the images provided, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of reey2674 showed one other similar product complaint(s) from this lot number.
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