H10: the device was not received for evaluation; therefore, a device analysis could not be completed.However, the condition of no flow, as reported in the event description, was determined to be a machine related issue during the manufacturing process.A nonconformance 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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