H10: the device was not received for evaluation, however photos were received.The visual inspection observed an external blood leak and internal air leak from the return screwed connector.The return screwed connector could not be closely examined.The reported condition was verified.The cause could not be determined.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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