Convatec Form 483 Includes Several Repeat Violations

An nine-observation FDA Form 483 to Convatec includes several repeat violations related to MDRs and design validation.

For example, the company did not validate a design change to its Flexi-Seal Control device. A marketing user study found that the change to the size and material of an inflation port component made it more difficult to deflate, but there was no additional evaluation or testing related to deflation before releasing the design change, according to the April 16 form, which was recently released. This issue was earlier cited during a February 2013 inspection.

Meanwhile, the directions for use state that the device is not intended for use on more than 29 consecutive days. However, no validation studies were conducted to ensure it will remain functional for that time period.

The FDA investigator also reviewed about 40 MDR-reportable complaints during the inspection and found they all lacked a determination of whether the device failed to meet specifications.

In another repeat observation, Convatec failed to report certain events as MDRs. Additional complaint-related observations included:

• Failure to submit a timely MDR for five complaints. This is a repeat observation from inspections in 2013 and 2010;
• Failure to submit a timely malfunction MDR for 22 events;
• Failure to submit a timely supplemental MDR for four reports; and
• Failure to submit certain information, such as details of operator error, with MDRs, which is a repeat observation.

Convatec declined to comment on the problems.

When it comes to device validation, make sure you're applying the right statistical tools and methods, and that you're using them correctly, in a proper way. Purchase Sample Size Considerations for Verification and Validation today!