One used sample was received for evaluation.Visual inspection revealed that the tubing was separated from the luer activated valve.Closer visual inspection of the tubing end showed the presence of a residual solvent bond.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.Thirty-three (33) unused companion samples were also received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pull testing was performed on the solvent bonds of the companion samples with no issues noted.The remaining two actual samples were not returned; therefore, a device evaluation could not be performed.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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