B5: this occurred during patient use.An alternative means of drawing blood was used to resolve the event.H10: the actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional pressure testing was performed and no leak was observed.The reported condition was not verified.According to the instruction for use (ifu) manual, the device is used for fluid administration, not fluid draw.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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