E1: initial reporter facility name: the actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the photos, it was observed that the cone of the return male luer lock was broken.The reported alarm was caused by the breakage.These components are preassembled and provided by a baxter supplier.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 determined to be related to supplier product design and manufacturing.A corrective action preventive action record and a change control were previously opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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