Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.Investigation summary: the device history report for lot number 7325365 was reviewed, no related abnormalities were found.Material number 383033 for lot 7325365 was manufactured on december, 2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Unfortunately a sample could not be obtained for the purpose for the investigation.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
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