Bard Hit with Wide-Ranging Warning Letter

Bard has announced that it has received a warning letter citing quality system and medical device reporting violations.

Qmed Staff

The Los Angeles District office of the FDA has handed Bard a warning letter, it revealed in an SEC document. The document mentioned quality systems and medical device reporting violations that FDA had identified earlier in Form 483 documents related to audits of its facilities in Glens Falls, NY and Tempe, AZ.

FDA determined in the warning letter that the company had been distributing its Recovery Cone Removal system, models RC-15 and FBRC, for removing filter implanted vascular filters without appropriate approval.

The agency will refrain from approving any premarket submission for the company's related Class III devices until the issue is resolved.

The warning letter also states that the company's IVC Denali filter delivery system is misbranded and that the company mistakenly reported complaints.

Furthermore, FDA states that the company failed to follow the proper protocols for complaints at the aforementioned NY and AZ facilities. The agency maintains that both facilities lack adequate instructions for handling complaints related to components and medical devices made by a contract manufacturer.

The agency also states the Bard incorrectly filed complaints related to its filters. One case involving its G2 filter "was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death," the letter states. And a series of malfunctions related to its filters "should have been filed as serious injuries."

While Bard is working to resolve the problems outlined in the warning letter, it stopped short of assuring the agency that it would be satisfied with its response to the warning letter or the date the matters outlined in the warning letter would be resolved. Furthermore, the FDA notice explains that the "company does not at this time believe this will have a material impact on its financial statements."

Finally, the warning letter states that its Glens Falls, NY-facility failed to properly validate its VC filter cleaning protocols for its Simon nitinol, Eclipse, and Denali filters.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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