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 guard is inconclusive due to the returned state of the sample.One 20 g x 0.75 in.Miniloc winged infusion set in an opened package was returned for evaluation.An initial visual observation showed no obvious evidence of use.A blue dust cap was returned on the luer hub of the infusion set, and one wing of the infusion set was returned in the cardboard of the packaging.No needle guard was returned.The opened state of the packaging made it difficult to assess when and where the needle guard went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of ascxs0024 showed no other similar product complaint(s) from this lot number.
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