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.
Facilities are required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient or employee of the facility.
The FDA receives voluntary reports on other serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that facilities suspect is associated with the use of an FDA-regulated drug, biologic, dietary supplement or cosmetic.
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.