Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Medical device lot #: 6141772, medical device expiration date: 5/31/2017, device manufacture date: 5/20/2016.Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of either lot.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.
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