(b)(4).The device was returned for evaluation.Microscopic inspection was performed and there was one black fiber, approximately 1.5 mm long, found between the inner and outer pouches.The cause of the condition could not be determined.A capa has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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