The data files and sheath, 4fc12 with lot number 53064, were returned and analyzed.The data files confirmed system notice 50032 (outer vacuum compromised) that was unrelated to the reported event.Visual inspection of the sheath showed the stopcock distal end luer was completely detached from the side port tube proximal end.In conclusion, the reported stopcock detachment was confirmed through testing.The sheath, 4fc12 with lot number 53064, failed the inspection due to stopcock detached from the side-port tube.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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