FDA Cites Bard For Additional Safety Violations Regarding IVC Filters
March 04, 2016
The FDA provides minimum safety regulations regarding the manufacture and post-market surveillance of medical devices to which manufacturers must comply. In July 2015, the FDA issued a lengthy warning letter to C.R. Bard, Inc. finding that the company had violated numerous minimum safety regulations relating to its Inferior vena cava (IVC) filters. These violations include failing to report numerous device failures and/or reporting serious patient injuries as if no injury had occurred. Bard was also found to have failed to establish an adequate manufacturing procedure to ensure that its IVC filters were appropriately manufactured. Just eight (8) months later, and the FDA has again notified Bard of numerous violations.
According to a recent court filing by Bard, it was notified in March 2016 of multiple additional safety violations regarding its IVC Filters. Specifically, the FDA notified Bard that its post-market trending procedure used to identify safety issues with its past IVC filters, does not comply with the FDA’s minimum safety regulations. Similarly, Bard was again cited for not complying with its own manufacturing procedures.