H11: additional information added to h3, h6 and h10 the actual sample was not available for investigation, however, photos were provided.Visual inspection observed that the cone of the return male luer lock was broken.The reported condition was verified.The cause was design related.This issue is being further investigated.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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