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.Powerloc winged infusion set with a y-site with open package for a 20 g x 0.75 in.Powerloc winged infusion set was returned for evaluation.An initial visual observation showed a clear fluid in the tubing of the returned sample.Both pinch clamps of the infusion set were found to be engaged and a white end cap was observed on the y-site.No end cap was found on the proximal luer connector, and the safety mechanism was observed to not be engaged.A cardboard insert, ifu, and a pre-flush sticker were returned in the open package.No needle guard was observed on the returned sample or within the returned packaging.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 asdrs0105 showed no other similar product complaint(s) from this lot number.
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