H10: one device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, including pressure and clear passage testing was performed with no issues noted.During the luer lock collar verification, it was identified that the collar of the two piece luer lock was not able to turn.The reported condition was verified.The presence of solvent was due to a manufacturing issue.The remainder of the 14 devices were not received for evaluation; therefore, a device analysis could not be completed.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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