The actual device was not available; however, photographs of the sample was provided for evaluation.The visual inspection of the provided pictures showed that the cone of the male luer connector (mll) of the return line is cracked.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was not determined.Additional recommended instruction is provided with this device for how to connect the female luer lock and the male luer.Should additional relevant information become available, a supplemental report will be submitted.
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