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.Reported to fda on november 20, 2014.
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