Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Lab analysis of the device: 1 syringe of juvederm ultra xc (lot h24la60076) received.1.0 ml used syringe with 0.5 ml of gel remaining in it received with a cap, no needle in a voluma with lidocaine pack (vb20a60523).No defect observed to syringe, nor to remaining gel.Device history record summary: the documentary research in the batch file shows that no element could explain these issues: all the syringes are inspected individually after filling and no problem was detected.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).All the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conform to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.The production line clearance done on each batch was in conformity and the double check performed at end of batch by 2 different operators was conforming.These 2 batches were not manufactured at same time, it is impossible that stickers of vb20a60523 could be found in a pack of h24la60076, as the lot vb20a60523 was manufactured 8 months later.It is hypothesized that there was a mix up at the physician's office, but cannot be ascertained.Device labeling addresses the reported events as follows: composition one syringe contains 1ml of juvéderm ultra® xc.Description juvéderm ultra® xc is a sterile pyrogen-free physiological solution of cross-linked hyaluronic acid (ha) which is not of animal origin.The gel is presented in a graduated, pre-filled, disposable syringe.Each box contains two 1ml juvéderm ultra® xc syringes, 4 single-use 30g1/2¿ sterile needles to be used only for injecting juvéderm ultra® xc, an instruction leaflet and a set of labels in order to ensure traceability.
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Healthcare professional reported having a syringe labeled as juvéderm ultra® xc that was half full of product that was found in a box and packaging of juvéderm® voluma® with lidocaine.The device was never used.The box and packaging trays were still sealed when the syringe was found.This is the same event reported under mdr id #3005113652-2017-00612 ((b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra xc, also a device manufactured by allergan.
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