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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a frayed guidewire is confirmed but the exact cause remains unknown.One 18 ga powerglide pro device was returned for evaluation.The product sticker label indicated lot: reex1227.The catheter was not returned with the device and the safety mechanism was successfully activated over the needle tip.Blood residue and evidence of use was present on the device.The guidewire was observed to be frayed and elongated.Microscopic observation of the core wire and coil wire did not reveal the weld tip to be present.The event description indicates fraying of the wire occurred during removal.Based on the information provided, retraction against resistance and damage against the needle bevel.Since the guidewire was observed to be frayed, the complaint is confirmed but the exact causing factors during use remain unknown.H3 other text : evaluation findings are in section h.11.
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