Initial reporter address: (b)(6).The device was not received for evaluation, however a photograph was provided for evaluation.The visual inspection of the provided picture showed that the cone of the male luer lock of the access line was broken.The reported condition was confirmed.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.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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