Based on the available information, this event is deemed to be a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional information was requested, but no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.This complaint involves eight 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.
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