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Catalog Number 94154EC |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/30/2017 |
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.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling addresses the reported event(s) as follows: precautions ¿ juvéderm® ultra xc 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.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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Healthcare professional reported that with one syringe of juvéderm ultra¿ xc, the ¿product was hard to inject.¿ it was explained that ¿first during product transfer from juvederm ultra xc original syringe/needle to a tuberculin syringe.¿ healthcare professional injected the patient¿s lips with the tuberculin syringe and had difficulty extruding the product.Patient contact was made.No injuries were reported.Healthcare professional later reported that the packaged needle was used ¿for product transfer.¿ the product was stored at ¿room temperature.¿ it was confirmed that the needle on the on the tuberculin syringe, used for the injection, has a ¿8mm length needle 31g.¿.
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Manufacturer Narrative
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Device analysis: empty syringe of 1.0 ml received without cap, no needle.No defect observed to syringe.
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Event Description
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Healthcare professional reported that with one syringe of juvéderm ultra¿ xc, the ¿product was hard to inject.¿ it was explained that ¿first during product transfer from juvederm ultra xc original syringe/needle to a tuberculin syringe.¿ healthcare professional injected the patient¿s lips with the tuberculin syringe and had difficulty extruding the product.Patient contact was made.No injuries were reported.Healthcare professional later reported that the packaged needle was used ¿for product transfer.¿ the product was stored at ¿room temperature.¿ it was confirmed that the needle on the on the tuberculin syringe, used for the injection, has a ¿8mm length needle 31g.¿.
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Search Alerts/Recalls
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