Reporting Tip
MedSun: Newsletter #19, December 2007

You may have wondered why we often ask if you returned the device involved in a report to the manufacturer, or suggest that you do so. We would like to clarify how this adds value to your report.

In many cases, in order for FDA analysts to obtain meaningful information when they contact the manufacturer about your report, the manufacturer, understandably, needs to have had the opportunity to examine the device. If you were not able to provide the device to the manufacturer, they will often respond that they simply cannot comment on what may have occurred with a device that they could not examine or they may state that the adverse event cannot be attributed to their device. In such cases, the FDA’s ability to follow up on your report, however well written, may be very limited.

We understand your concern about releasing a device that has potential to be involved in litigation, to the manufacturer. Putting those instances aside, we strongly suggest that you make every attempt to return defective or problematic devices to the manufacturer for analysis. Or you can request an on-site manufacturer analysis. This, of course, is a necessity with large fixed devices such as CT scanners. Alternatively, if the device is not available, you can inform the manufacturer that you are sending an unused device from the same lot # for evaluation instead. In instances where the packaging was thrown away and all device identifiers are therefore not available, returning the device to the manufacturer allows FDA to get more device identifiers from the manufacturer after the device is examined.

If you have questions about how to return products to the manufacturer for analysis, contact your hospital’s Material Management or Purchasing department. In most cases they have frequent contact with representatives from these companies and have procedures in place for returning items to them. All parties have the opportunity to benefit when a device involved in an adverse event is returned to the manufacturer; the FDA is better able to follow up, the manufacturer gains a better understanding of failures that occur with its product, and you may learn some lessons about the use of that product or what the manufacturer may be doing to prevent a future occurrence.


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