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C. R. Bard Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard), and AngioDynamics, Inc., manufactured vascular access ports that were inserted under a patient’s skin to enable medical providers to insert fluid into the patient’s veins without having to initiate a new intravenous line. The Food and Drug Administration (FDA) warned medical providers not to use vascular access ports for power injection unless the ports were labeled for such use.
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Bard sold vascular ports that could be used for power injection, even though they had not been approved for such use by the FDA. Bard then developed detectible information that would dependably indicate the power injection function after the implanting of the port, using a radiographic marker with the letters “CT” etched in titanium foil. Bard included other identifiers that could be felt through the skin, as well as labeling on the packaging of the device. Bard received FDA approval for its power injection device marketed under the brand PowerPort.