(b)(4).The device manufacturing date was between july 24, 2015 and july 28, 2015.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.Visual inspection did identify the presence of particulate matter on the cannula.The cause of the condition could not be determined.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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