The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of failure of the safety mechanism to activate during device removal was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 20ga x 1" safestep safety infsuion set.The investigation findings were consistent with misplaced or excess manufacturing adhesive, which bound the safety mechanism to the needle.The following observations were made during the sample evaluation: the safety mechanism was not engaged over the needle tip and was returned positioned at the needle base.The safety mechanism was eventually engaged over the needle; however, forceful advancement of the mechanism was required.The needle shaft and safety mechanism were both examined and were determined to be undamaged and thus were not suspected to have contributed towards the event.Microscopic examination under uv light assistance revealed a white/clear adhesive-like substance at the interface of the needle shaft and safety mechanism.That material fluoresced under ultraviolet light, which was consistent with the adhesive used to assemble the infusion set.From this, it appeared that adhesive was deposited on the needle shaft during device manufacture.The device is a supplied component and the supplier was notified of the event.A lot history review (lhr) of asdqs0031 showed no other similar product complaint(s) from this lot number.
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