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 difficulty activating the safety mechanism was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 22ga x 0.75" safestep safety infusion set.The returned product sample was evaluated and the needle was observed to be bent near the non-engaged safety mechanism.The following observations were noted during the sample evaluation: ¿ usage residue was seen on the sample which proved that the product had experienced at least some use ¿ the bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access ¿ the needle tip was barbed suggesting contact between the needle and port base resistance was encountered when trying to advance the safety mechanism metal sleeve over the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.
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