Further information regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event(s) as follows: "method of use ¿ posology ¿ remove tip cap by pulling it straight off the syringe as shown in fig.1.Then firmly push the needle provided in the box (fig.2) into the syringe, screwing it gently clockwise.Twist once more until it is fully locked and has the needle cap in the position shown in fig.3.If the needle cap is positioned as shown in fig.4, it is incorrectly attached.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig.5, and pulling the two hands in opposite directions.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.".
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