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 accucath placement complications was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced.The safety button was depressed and the needle was fully withdrawn in to the housing.The catheter exhibited extensive buckling and kinking along its entire length.The guidewire was broken proximal of the coil.The distal wire fragment was not returned.Microscopic inspection of the catheter confirmed extensive deformation.The tip of the catheter was buckled inward.Microscopic inspection of the guidewire break revealed a granular fracture surface.Necking was observed in the vicinity of the break.The catheter tip deformation was consistent with attempted advancement against resistance, such as into tissue.The catheter shaft deformation was consistent with compression caused by guidewire retraction against the deformed catheter tip.The break in the guidewire was consistent with tensile failure caused by pulling.Combined, it appeared that initial placement was attempted into tissue, causing catheter tip damage and subsequent removal attempts compressed the catheter and broke the guidewire.H3 other text : evaluation findings are in section h.11.
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