Seal Failure

Loss of containment or unintended leakage that arises when a sealing element or sealing interface between mating surfaces (e.g., gasket, O‑ring, mechanical seal, flange joint) no longer prevents fluid transfer due to degradation, deformation, displacement, incorrect installation, or operating conditions exceeding design limits.

Loss of an intended tissue–device or device–device barrier (hermetic or functional seal) that allows unintended passage of liquids, gases, or biological agents across an interface and impairs the device’s designed containment, pressure integrity, or infection barrier.