(b)(6).The device was not received for evaluation; however, pictures were received.Visual inspection observed white deposits in the area of the end cap.The ultrafilter is not responsible for the failure of 'particulate matter inside fluid path¿ it only fulfills its function as a water filter.No product defect was observed.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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