H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 a stuck guidewire was confirmed.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.Blood residue was abundant within the needle shaft.The wire was fully withdrawn into the housing.The safety button was depressed; however, the needle was not withdrawn into the housing.Microscopic inspection of the sample confirmed blood residue within the needle shaft, which appeared to be bonding the wire to the needle.Attempts to advance the wire were unsuccessful.The wire was not mobile within the needle.The observed inability to advance the guidewire appeared to be caused by blood product coagulation within the needle shaft.This can occur if blood is allowed to coagulate within the device prior to guidewire advancement.H3 other text : evaluation findings are in section h.11.
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