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, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent guidewire was confirmed but the cause is unknown.A single photograph of the sterile field from the procedure was returned for evaluation.Multiple components were in the photograph including a syringe with a hypodermic needle attached, a scalpel, an introducer needle, the d/l powerpicc catheter, and the guidewire with the guidewire hoop.The guidewire had been circled in the photograph, indicating that is where the implicated issue was.A single bend was seen in the guidewire.It could not be determined from the returned photograph is the bend in the guidewire resulted in the coils of the coil wire being displaced.No breaks or elongation of the wire were evident in the photographed wire.It was reported that the guidewire had become bent prior to inserting the picc.Possible contributing factors could include damage due to inserting the guidewire against resistance or the guidewire snagging on an interfacing component (e.G., needle or dilator).A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.As it could not be determined how or when the guidewire became bent, this complaint will be recorded as cause unknown.
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