E1: initial reporter facility name: (b)(6).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 male luer lock (mll) was broken.This component is provided preassembled 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 manufacturing and the mll design.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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