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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle cover is inconclusive due to the state of the returned sample.One 22 g x 1 in.Safestep infusion set with a valved y-site was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.A cap was returned on the proximal luer hub, but no needle guard was returned on or with the returned sample.While no needle guard was returned on or with the returned sample, the sample was returned outside of any packaging which made it difficult to determine when and where the component may have gone missing.
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