Based on the available information, this event is deemed a reportable malfunction.There were no reports of patient being harmed as a result of this malfunction.No additional patient/event details have been provided to date.A return sample for evaluation has not been received however a quality evaluation is in progress.Should additional information become available, a follow-up report will be submitted.This complaint involves twelve different lots; therefore additional records have been created in order to capture this information and separate fda form 3500a's has been generated to address the other cases.(b)(4).
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