Product event summary: the 4fc12 sheath with lot 0010925125 was returned and analyzed.Visual inspection of the handle area was performed.The inspection identified that the stopcock was detached from the side port tube; the stopcock was not returned.Insertion of dilator into the sheath was performed.It was not possible to lock the dilator luer into the sheath.Further inspection under a microscope identified dilator luer damage.In conclusion, the sheath failed the returned product inspection due to a detached stopcock from the sheath.If information is provided in the future, a supplemental report will be issued.
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