Initial reporter phone number:¿ (b)(6).Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The actual device was not available; however, photos of the sample were provided for evaluation.Their visual inspection showed that the cone of the return male luer lock was broken.The reported condition was verified.The cause was design related.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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