Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformance's noted.Device labeling addresses the reported event(s) as follows: "precautions for use.If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle.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.Inject slowly.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level.".
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During injection to the nasogenian fold with 1 syringe of juvéderm ultra¿ xc, the healthcare professional experienced ¿difficulty in pushing the plunger.¿ once the injector changed the packaged needle to another one from the box, the ¿product came out normally.¿ the injector thinks that ¿the needles of this box were clogged.¿ no injury was reported.
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