Pharmacist's Unsafe Device SafeWatch Report Leads to a Class I FDA Recall

Jessica Schad, a Pharmacist at Carilion Roanoke Memorial, reported an unsafe device concern in SafeWatch.  In addition to Jessica's report, two additional reports were received leading to a voluntary report to the FDA by Carilion's Patient Safety Team. The FDA recently announced that Jessica's report along with other similar reports lead to a Class I Recall, the highest and most urgent recall possible.    

The FDA calls for a Class I Recall when a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

On behalf of the Clinical Advancement and Patient Safety department, thank you, Jessica for recognizing and reporting this unsafe device.  This report lead to actions by the FDA which will keep patients safe not only at Carilion but worldwide.    

If you are aware of an unsafe medical device, a device is unsafe to operate, or a devices fails/breaks during use be sure to save and sequester the device and submit a SafeWatch report.