Catalog Number 94154 |
Device Problems
Gel Leak (1267); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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: 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.Health care professional instructions 9.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.
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Event Description
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Health professional reported that during injection with juvéderm® ultra xc the "product was not flowing out properly even though pressure was applied¿ and the needle "popped off and the product was lost." no injury to the patient or injector.The packaged needle was used.
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Event Description
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Health professional reported that during injection with juvéderm® ultra xc the "product was not flowing out properly even though pressure was applied¿ and the needle "popped off and the product was lost." no injury to the patient or injector.The packaged needle was used.
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Manufacturer Narrative
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Device analysis: empty syringe of 1.0 ml received without cap, no syringe.No defect observed to syringe.
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Search Alerts/Recalls
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