The QMN Weekly Bulletin

FDA Issues Warning Letter to C.R. Bard Over Quality Systems, Unapproved Devices

Aug. 28, 2015

The FDA has come down on C.R. Bard for not addressing quality systems and medical device reporting observations at two of its plants.

In a far-ranging July 13 warning letter, the FDA details problems found at facilities in Tempe, Ariz., and Queensbury, N.Y., during separate inspections in 2014 and the beginning of this year. The inspectors noted their findings in Form 483s, and the FDA deemed many of the company’s responses inadequate.

According to the warning letter, Bard is manufacturing two recovery cone removal systems without the required clearance or approval at its Tempe peripheral vascular facility. Model RC-15, which is intended to percutaneously remove certain inferior vena cava filter delivery systems, is not included as part of the clearances for any of these filters.

The letter also advises Bard that the Recovery Cone Removal System, Model FBRC, is adulterated because the company doesn’t have an approved PMA or IDE application for the product. Although the company lists the model as a Class I surgical snare, the FDA says there is evidence that it is intended for uses that are different from legally marketed devices.

“Devices of this type usually consist of a non-powered, hand-held, or hand-manipulated device that is either reusable or disposable, which are intended to be used in general surgical procedures,” according to the letter.

Bard is marketing this model for the percutaneous removal of IVC filters, a specialized intended use.

FDA Advises Bard to Stop Distribution

The FDA says Bard has yet to submit a response about violations and advises the company to stop commercial distribution of the devices for unapproved uses.

Inspectors also cited Bard for not establishing and maintaining procedures for receiving, reviewing and evaluating complaints. The letter refers to instances in which device malfunction reports should have been filed as serious injuries and, in one case, death, occurred.

In addition, there were at least 10 patients who underwent unsuccessful surgical procedures to remove an IVC filter. The complaint files do not contain enough information to conduct an adequate investigation, the warning letter notes, such as potential patient complications due to leaving the filter longer than expected.

Moreover, complaint investigation procedures don’t include adequate instructions for ensuring that complaints about devices or device components provided by a supplier are “adequately evaluated for root cause of the alleged device failure and that appropriate corrective action is implemented with your supplier,” the letter says.

Bard submitted 11 separate responses — six from the Queensbury plant and five from the Tempe facility — but the FDA called them insufficient. A Jan. 26 response from the Tempe facility cited clerical errors and noted it had “opened a CAPA to track training and determination of root cause with corrective and preventive actions,” according to the warning letter. However, the FDA said this doesn’t ensure that complaints are evaluated adequately.

Further Validation Needed

The letter also knocks the New York facility for failing to validate a manufacturing process that inspection and testing could not fully verify.

Specifically, the FDA said that IVC filter cleaning, “to include removal of chemical processing contaminants, has not been validated.”

The agency found Bard’s response is partially adequate, given that the company has made progress validating the cleaning processes for Denali filters and the Simon nitinol filters. However, a follow-up inspection will be necessary to fully evaluate Bard’s actions. Also, while the company has performed “exhaustive extraction testing” of the Denali filter made by one of its suppliers, the other uses a different manufacturing process, processing agents and equipment. The FDA said it wants Bard to perform similar testing on products from that supplier.

The FDA also chides Bard for not providing an adequate response for MDR violations at the Tempe facility. In one instance, a complaint described a malfunction of a long-term implant, but Bard failed to rule out that a recurrence of the problem was unlikely to result in serious injury or death.

In a Securities & Exchange Commission filing, Bard acknowledged receiving the letter and promised to take action.

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