Do I have to report a needlestick-related event that involves blood spillage or splattering?
You do not need to report a device-related blood spillage or splattering event unless the incident is the result of a device malfunction. If you are a manufacturer or an importer, you should report any spillage or splattering malfunction event if a recurrence is likely to cause or contribute to a death or serious injury. • Do I have to report a needlestick-related event due solely to user error? It depends on the severity of the event. Events involving a death or a serious injury where user error may have caused or contributed to a needlestick-related event are reportable by a user facility, importer, and manufacturer. • As a manufacturer, what type of follow-up investigation should I conduct for events involving needlestick-related devices? We require that you make a “good faith effort” to obtain information about the event. 21 CFR 803.50. You should document all follow-up attempts and reasons why any of the required MDR information could not be obtained. You should include in your fi
