(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "not happy with the results" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device analysis: visual analysis of the returned device noted no defect was observed.Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling addresses the reported event(s) as follows: "precautions: 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.".
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