Catalog Number 94640 |
Device Problems
Leak/Splash (1354); Occlusion Within Device (1423); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2018 |
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.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: 5.Precautions ¿ juvéderm voluma® xc is packaged for single-patient use.Do not resterilize.Do not use if package is open or damaged.¿ 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.8.Instructions for use b.Health care professional instructions 6.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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Healthcare professional reported one syringe of juvéderm voluma® xc had ¿the product became very hard¿ and would not push out of the syringe.The healthcare professional went on to advised that the needle ¿exploded off and the product spilled out.¿ patient contact occurred.No injuries were reported.The packaged needle was used and this was the confirmed initial use of the syringe.
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Manufacturer Narrative
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Device analysis summary: visual analysis of the device indicates no defect observed.
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Event Description
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Healthcare professional reported one syringe of juvéderm voluma® xc had ¿the product became very hard¿ and would not push out of the syringe.The healthcare professional went on to advised that the needle ¿exploded off and the product spilled out.¿ patient contact occurred.No injuries were reported.The packaged needle was used and this was the confirmed initial use of the syringe.
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Search Alerts/Recalls
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