(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device analysis: visual analysis of the returned device noted "1 empty syringe of 1.0ml received with cap and without needle.No defect observed." device history record summary: the release step combined with the absence of any deviation shows that no element could explain this issue: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.All the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling addresses the reported event(s) as follows: "precautions - failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.".
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Healthcare professional reported 1 syringe of juvéderm® ultra plus xc had "the needle disengage during injection." patient contact did occur.No injuries occurred to any party."when the injector does injections in droplets, each time, the needle twists slightly and the injector has to retighten it each time.When it's just one push, it is fine, but the droplet injections cause the twist of the needle." packaged needle was used.
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