Warning Cites Complaint Handling After Incident of Fecal Matter Exposure

ConvaTec failed to document its adverse event decision for a complaint about a patient exposed to fecal matter on a skin grafting after a “balloon came out, half inflated,” an FDA warning letter says.

The company’s representative performed testing and discovered a hole “in the area between the finger pocket and the balloon body, on the outside surface,” which the company designated a product issue. According to the May 24 warning letter, ConvaTec does not always review and evaluate complaints classified as product issues.

The warning follows a Form 483 issued at the conclusion of a Jan. 8 through Feb. 5 inspection by the FDA’s New Jersey district office.

The Skillman, N.J., company, which makes temporary containment devices for immobilized patients, also failed to evaluate for reportability a complaint about a retention balloon that tore into the anal canal after four days, resulting in stool leakage. That complaint was also classified as a product issue.

ConvaTec’s post-inspection response was inadequate “because by ‘categorizing’ the complaint as a ‘product issue,’ your firm has determined that the complaint does not meet the procedural definition of either an adverse event or product malfunction and therefore it would not meet the ‘reportability criteria,’” the letter says. However, “all complaints need to be evaluated and not categorized” in order to determine reportability.

The company also failed to implement its design control and change control procedures for an upgraded device, which included an added cinch clamp. And the design verification plan for the change evaluation plan did not reference a variable sample standard or provide a statistical rationale for certain samples that were required for the cinch clamp leak verification study, the letter says.

In a repeat observation, ConvaTec also did not implement its corrective and preventive action procedures. According to the warning letter, a third-party manufacturer assigned the same lot code to two different items. While ConvaTec’s action plan involved updating the product specification to clarify coding requirements, it did not require the company to verify the effectiveness of this step.

“Furthermore, your firm stated during the current inspection that no action was taken regarding the mixed lot products where the disposition of the products was not documented within the nonconformance record,” the letter says.

The FDA instructs ConvaTec to arrange an audit of its manufacturing and quality assurance systems by an outside expert consultant. A copy of the consultant’s report and certification that ConvaTec’s CEO has reviewed the report and the company has initiated or completed the consultant’s recommendations should be submitted to the agency by Sept. 15. By Sept. 15, 2014, the company should provide any subsequent certifications of updated audits or corrections, if needed.

ConvaTec said it is working with the FDA to resolve the issues in a timely manner and is committed to thoroughly addressing all of the agency’s concerns.

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