Catalog Number 94703RX |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2017 |
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: "method of use - posology ¿ juvéderm® volift¿ with lidocaine is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.".
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Event Description
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Healthcare professional reported to a company representative that they ¿couldn¿t put the cannula 25g on the syringe correctly¿ with 1 syringe of juvéderm® volift¿ with lidocaine.Product was ¿wasted¿ and ¿leaked on the side.¿ problem location was noted to be at the ¿damaged¿ luer lock.Event ¿did not occur when a needle was used.¿ healthcare professional tried again with another cannula, but the problem remained the same.There was a loss of 0.2ml of product.Patient contact was made in the nasogenian fold.Injection in the ¿nasojugal fold¿ was not performed due to the ¿damaged¿ luer lock.There were no injuries to the patient.
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Manufacturer Narrative
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Device analysis: 1.0 ml syringe with 0.3 ml of gel remaining in it received with a cap, 1 unused needle, 1 used cannula in an opened volift tray.No defect observed to syringe.
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Event Description
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Healthcare professional reported to a company representative that they ¿couldn¿t put the cannula 25g on the syringe correctly¿ with 1 syringe of juvéderm® volift¿ with lidocaine.Product was ¿wasted¿ and ¿leaked on the side.¿ problem location was noted to be at the ¿damaged¿ luer lock.Event ¿did not occur when a needle was used.¿ healthcare professional tried again with another cannula, but the problem remained the same.There was a loss of 0.2ml of product.Patient contact was made in the nasogenian fold.Injection in the ¿nasojugal fold¿ was not performed due to the ¿damaged¿ luer lock.There were no injuries to the patient.
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Search Alerts/Recalls
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