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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a guidewire issue is confirmed but the exact cause could not be clearly determined from the photo samples provided.Two photo samples of an accucath needle were provided for evaluation.Only the needle portion of the device is visible in the first photo.Red blood residue is present on the paper behind the needle.The guidewire is shown extended from the flash notch on the side of the needle.The second photo sample shows the needle to be partially retracted in the device housing.The needle is still exposed.The guidewire is sticking out at an angle.The guidewire protruding from the flash notch appears to be causing the issue with the needle retraction safety.The conditions of use or issue with the device could not be determined; therefore, the complaint is confirmed, cause unknown.Based on the photos provided, possible contributing factors include advancement of the guidewire against tissue.A lot history review (lhr) of redx2355 showed one other similar product complaint(s) from this lot number.The complaints for this lot number: (redx2355) have been reported from the same facility.
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