The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent infusion set needle was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 20ga x 1" powerloc ez safety infusion set.The returned product sample was evaluated and the needle was observed to be bent near the exit site from 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 needle tip was barbed suggesting contact between the needle and port base.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass 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.A batch history review (bhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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