10415.1 If you are a user facility, you must submit reports to the manufacturer or to the Department or both, as specified below:

(a) When reporting a death, you must submit a report to the Department as soon as practicable but no more than ten (10) work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known; or

(b) When reporting a serious injury, you must submit a report to the manufacturer of the device no later than ten (10) work days after the day you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to the Department.

10415.2 You must submit all information required in § 10416 that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable follow-up within your facility. You are not required evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).