Initial reporter address: (b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photographic sample was reviewed, and it was noted that the cone of the effluent male luer lock (mll) was broken.The observed leak was likely due to a broken mll cone.The reported condition was verified.The most probable cause was a manufacturing issue.A nonconformance has been opened to address this issue.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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