|Recovery Cone Removal System--Courtesy of C.R. Bard|
C.R. Bard ($BCR) revealed in an SEC filing that its facilities in Glens Falls, NY, and Tempe, AZ, are under an FDA warning letter for misfiling customer complaints--including the report of a patient death, manufacturing the Recovery Cone Removal System without the required clearance or approval, and failing to inform the agency of serious device malfunctions.
The filing said until the company addresses the issues, the FDA will not approve premarket submissions of high-risk, Class III devices "to which the non-conformances are reasonably related." Bard said in the filing it has one such submission before FDA, "which the company does not believe is material to its business."
The Recovery Cone Removal System is used to retrieve inferior vena cava filters. IVC filters capture embolisms (or blood clots) that form in the veins of the legs before they reach the heart or lungs, which could result in injury or even death.
The FDA said that model RC-15 of the Recovery Cone was not included in the clearance of 4 IVC filters. In addition, the warning letter, addressed to Bard CEO Timothy Ring, states that the model FBRC violates the Federal Food, Drug, and Cosmetic Act because "you introduced or delivered into interstate commerce for commercial distribution a device with major changes/modifications to the intended use without submitting a new premarket notification to the agency as required by section 510(k)," citing a part of the Code of Federal Regulations.
The letter also raises concerns about Bard's adherence to Quality System Regulations at the Tempe facility. For example, it states that a complaint related to the G2 IVC filter, about embolization of a detached filter arm "was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death." Other complaints were also misfiled, while other files did not contain enough information, the FDA said.
|Denali inferior vena cava filter|
A variety of QSR violations are also noted regarding the Queensbury facility, such as unvalidated cleaning processes for the Denali IVC filter.
Lastly, the Tempe facility was also cited for violating Medical Device Reporting requirements, meaning the plant did not inform the FDA within 30 days of receiving complaints or information suggesting that one of its devices has malfunctioned and is likely to lead to death or serious injury.
Bard was previously made aware of these violations following inspections via the FDA's Form 483 of inspectional observations, but the agency was unhappy with the company's response and steps taken to correct the problem, so it has taken the more serious step of issuing a warning letter and suspending the marketing application of certain unapproved devices.
- read the letter