Facilities must report patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended, whether or not the use is intended or described by the device manufacturer's literature. Includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, ventilators, and procedural and monitoring equipment.

Facility must report patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting, including contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product. Intended to capture contaminations that can be seen with the naked eye or with use of detection mechanisms in general use. Contaminants may be physical, chemical, or biological in nature. Includes administration of contaminated vaccine or medication (e.g., intramuscular antibiotic); serious infection from contaminated drug or device used in surgery or an invasive procedure (e.g., a scalpel); occurrences related to use of improperly cleaned or maintained device.

Facilities must report patient death or serious injury associated with intravascular air embolism that occurs while begin cared for in a healthcare setting, excluding those associated with neurosurgical procedures known to present a high risk of intravascular air embolism. Intended to capture high-risk procedures, other than neurosurgical procedures, that include, but are not limited to, procedures involving the head and neck, vaginal delivery and caesarean section, spinal instrumentation procedures, and liver transplantation; low-risk procedures, including those related to lines placed for infusion of fluids in vascular space.