2024-18267. Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device

Table 1—Intravenous Catheter Force-Activated Separation Device Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Delays of therapy due to failure of device to function as expected ( e.g., if separation force too low)	Performance data, Non-clinical performance testing, and Labeling.
Mechanical complications ( e.g., IV dislodgement, IV infiltration, occlusion, and phlebitis events requiring IV replacement) due to failure of device to function as expected ( e.g., if separation force too high)	Performance data, Non-clinical performance testing, and Labeling.
Infection	Sterilization validation, Shelf life testing, Non-clinical performance testing, and Labeling.
Air embolism	Non-clinical performance testing, and Labeling.
( print page 66560)
Adverse tissue reaction	Biocompatibility evaluation, Pyrogenicity testing, and Non-clinical performance testing.