(b)(4).The device was manufactured between the dates of 11/13/2014 and 11/14/2014.The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed via the naked eye and microscope was performed, a black particle was noted approximately 0.02mm in size embedded in the stress member, outside of the fluid path.The reported problem was identified but the cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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