Additional information was added to d10, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specification.Verification of the luer lock (collar) revealed that it was stuck to the male adapter component; there was a trace of solvent application.The reported condition was verified.The cause of the condition is related to production during manufacturing.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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