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 22 g x 0.75 in.Safestep infusion set in an opened package was returned for evaluation.An initial visual observation showed the safety mechanism was activated and the pinch clamp was engaged.A clear fluid was observed within the tubing.The needle guard and end cap were not returned with the sample.The opened state of the packaging made it difficult to assess when and where the component(s) went missing.Usage residue was observed on components within the kit which made determination of the exact timing and location of the missing component impossible.As a result, the event could have occurred at the manufacturing facility or following opening of the kit at the user facility.A lot history review (lhr) of asbys0039 showed no other similar product complaint(s) from this lot number.
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