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.This report addresses sample 1.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 guidewire malfunction was confirmed.The product returned for evaluation was two 18ga powerglide pro midline catheter assemblies.Usage residues were observed throughout both samples.The catheters had been advanced and the safety mechanisms were engaged.The catheters were not returned for evaluation.The guidewire protruded from the needle of the first sample (sample 1).The guidewire did not protrude from the needle of the second sample (sample 2).During inspection of sample 2, the guidewire was observed to be disengaged from the wire advancer and coiled within the housing.Attempts to retract and advance the guidewire of sample 1 were successful and unremarkable.Attempts to advance the guidewire of sample 2 were unsuccessful because the wire was not engaged with the advancer.Following disassembly of sample 2, inspection of the advancer revealed wear marks in the coupler region.Inspection of the guidewire revealed it to be intact.A bend was observed within the nitinol region.The guidewire could not be advanced because it had become disengaged from the advancer.The wear marks on the coupler region indicated that the device was initially properly assembled.It appeared that the guidewire had become disengaged from the advancer through attempted advancement against resistance, such as into tissue.The use residue indicated that advancement occurred during attempted device use.The guidewire coiling and bend were also consistent with advancement against resistance.H3 other text : evaluation findings are in section h.11.
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