Catalog Number 95661 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/31/2019 |
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.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reported that prior to injection, a new box of juvéderm® vollure® xc was opened and one syringe had "black particulate specks" inside of it.No injury reported.
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Manufacturer Narrative
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Device analysis: one syringe of 1,0 ml with 0,75 ml remaining, received in the box with the 2 needles and in an open tray, but without syringe plug.2 black particles are observed on the gel, and a lot of bubbles.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.
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Event Description
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Additionally, healthcare professional believes the black specs "may have been part of the rubber material that the plunger ¿stopper¿ is made of.¿.
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformances noted.Based on the analysis, the particles observed in the gel correspond to polypropylene particles.The most probable root cause is particular contamination during the manufacturing process, as polypropylene fiber are used as material for clothes in clean room.No new risk was identified.
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Event Description
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Healthcare professional reported that prior to injection, a new box of juvéderm® vollure® xc was opened and one syringe had "black particulate specks" inside of it.No injury reported.Additionally, healthcare professional believes the black specs "may have been part of the rubber material that the plunger ¿stopper¿ is made of.¿.
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Search Alerts/Recalls
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