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According to the Food and Drug Administration, user facilities must submit a medical device adverse event report to the agency and the manufacturer if a device causes or contributes to a patient death or serious injury. Manufacturers and importers must file an adverse event report if they become aware that one of their devices caused or contributed to a serious injury or death, or if a device malfunction occurred that “would be likely” to cause or contribute to a serious injury or death.

Do you need to report needlesticks to the FDA?