Medical Devices

Report a Problem to the FDA

Luer and tubing misconnections are an under-reported problem in health care. Some misconnections are corrected before serious injury to the patient occurs. Increased awareness and analysis of these errors, including corrected error, can lead to improvement in patient safety. The FDA encourages you to report even if the misconnection was corrected prior to serious injury.

What to Include in a Report:

To help us learn as much as possible about the adverse events or problems associated with tubing misconnections, Luers and other small-bore connectors, please include the following information, if available, in your reports:

  • A detailed adverse event description; including where the correct connection was to be and what it was connected to.
  • All devices relevant to the event
  • All known device identifiers for the reported device or devices: model name, model number, brand name and catalog number and lot number
  • Patient outcome
  • Patient age and gender
  • Setting of adverse event (e.g. hospital, home, etc.)

Device Manufacturers:

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Health Care Professionals from User Facilities:

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Other Health Care Professionals and Consumers:

We encourage you to file a medical device report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
 

Page Last Updated: 11/27/2012
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