The reported ndl, gripper micro, 20g x 0.75" was returned for investigation along with an image and a video.The returned device was received on a container without its original packaging.Visual inspection was performed and the needle of the received sample was moved into the opening of the base and re-assembly to re-activate the safety mechanism.The needle was measured using a calibrated caliper and the click from the safety mechanism could be heard.There was no movement of the needle, and there was no part of the needle showing after it had been secured in place.The needle was measured and it was found that the needle was within specification.The picture and video resulted on the picture showing that the needle is out of the out of the safety mechanism, on the video it was detected that the needle came out of the safety mechanism after the click from the safety mechanism was heard and a small pull is applied to the needle.The instructions for use or ifu state that "failure to use safety arm correctly (lift safety arm straight back to the lock position until it clicks) when removing needle from portal site could result in the needle tip re-emerging from the base, resulting in accidental needle stick with a contaminated needle.No root cause has been determined since the complaint was not confirmed.(b)(4).
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