The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty activating safety mechanism is confirmed to be supplier related.One 22 ga x 0.75 in safestep infusion set was returned for investigation.An infusion cap was attached to the luer connector.Use residue was present throughout the device.The safety mechanism was not advanced.An attempt to activate the safety mechanism revealed resistance.Residual material was observed between the metal sleeve and needle shaft.The residue appeared to be adhesive used in the manufacturing process.The color of the material appeared to be discolored due to the use residue.The safety was able to be successfully activated with the application of additional force.Since resistance appeared to have been caused by residual adhesive used in the manufacturing process, the complaint is confirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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