Device manufacture date: 8/12/2016-8/15/2016.Results: it is unknown if a sample will be returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6179705.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).
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