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 component is inconclusive due to the state of the returned sample.One 20 g x 0.75 in.Powerloc winged infusion set with y-site in an opened package was returned for evaluation.An initial visual observation showed obvious evidence of use.The needle shaft was observed to be slightly bent at its base.The needle guard was not returned with the sample.The opened state of the packaging made it difficult to assess when and where the component went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of ascys0071 showed no other similar product complaint(s) from this lot number.
|