The 4fc12 sheath with lot number 0010840719 was returned and analyzed.Visual inspection of the shaft area was performed.The inspection identified a shaft kink and twist at approximately 2.5 inches from the tip.The dilator was inserted into the sheath and retracted several times, without any friction.The dilator was snap-locked to the sheath and was tight.Visual inspection and magnifying with a high-resolution microscope showed the dilator luer and tip was intact without any issue.In conclusion, the sheath failed the returned product inspection due to the shaft kink and twist.If information is provided in the future, a supplemental report will be issued.
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