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Catalog Number 94640 |
Device Problems
Detachment Of Device Component (1104); Gel Leak (1267); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.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).The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.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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Event Description
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Healthcare professional reported that during injection with one syringe of juvéderm voluma® xc healthcare professional had the ¿tip of the syringe blow off,¿ the ¿needle disengaged,¿ and the product, ¿spilled.¿ patient contact did occur.No injury to patient, staff, or injector.
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Search Alerts/Recalls
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