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 difficult guidewire advancement was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter assembly.The sample was received fully assembled, with the catheter overlaying the needle.Blood residue was evident throughout the sample.Initial attempts to advance the guidewire were unsuccessful.The wire appeared to be adhered to the inside of the needle shaft by blood residue.Microscopic inspection of the sample confirmed the presence of abundant blood residue, including within the needle shaft.Following additional manipulation, guidewire movement was established.Following guidewire advancement, inspection of the distal end revealed misalignment of the coils.Microscopic inspection of the guidewire coil region revealed a kink in the distal most coil.The guidewire deformation was consistent with attempted advancement against resistance.The abundant biological residue indicated that advancement occurred during attempted device placement.Such deformation is typical of attempted advancement into tissue.A lot history review (lhr) of redn3252 showed no other similar product complaint(s) from this lot number.
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