(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review indicates no discrepancies.Machine logs have been checked and no discrepancies were found.Preventive maintenance logs were checked and were completed.A photograph has been received for this complaint, which was evaluated.The photographs confirmed the complaint issue and the batch number.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.
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