Medical Devices

Postmarket Information - Device Surveillance and Reporting Processes

Use Error Reporting

A use error refers to a situation in which the outcome of device use was different than intended, but not due to malfunction of the device. The error may have been due to a poorly designed device, or it may have been used in a situation that promoted incorrect usage. Other users may make the same use error with similar or worse consequences. You can help us identify these errors by reporting the actual events and near misses that occur at your facility.

When reporting an adverse event, reporters often leave out details of the event that can be useful in identifying the factors or conditions that led to the event. Reports are more helpful if you describe the scenario as concretely as you can.

Good example of problem description:

“Nurse was changing the concentration of a prescribed medication being infused through a pump. In programming a bolus before the concentration change, she misunderstood the default settings and accepted the bolus concentration as the final dose. As a result, the patient received a three-fold overdose.”

In addition to a full description, other important and helpful information to include in the report is:

  1. Device type, manufacturer, brand name, and lot number if applicable
  2. The exact location of the event
  3. Was the patient or device operator harmed?
  4. Was the problem with the device a defect, malfunction, break, etc.?
  5. Was someone directly “operating the device at the time of the event? If so, who?
  6. Were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event?

Postmarket Reporting of Adverse Events, Use Errors and Product Problems


Page Last Updated: 09/12/2014
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