The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned.
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H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 safety mechanism failure to activate was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 22ga x 0.75" safestep safety infusion 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 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.Corrective actions have been implemented by the supplier; however, it is unknown if the complaint sample was manufactured prior to or following that implementation.
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