The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, which is used with its Renasys line of negative pressure wound treatment devices.

In March 2013, the company distributed a bulletin to users notifying them of changes to the dressing design. The modifications were made after Smith & Nephew found that improper installation of the filter could result in failure to activate the full/blockage alarm, according to the June 11 warning letter published online. The company neither notified the FDA nor provided written justification for not doing so, the letter says.

Smith & Nephew’s Saint Petersburg, Fla., facility also found that the alarm function could be affected by small amounts of air leakage and changed the instructions for inserting the Renasys EZ and EZ Plus Pumps canister filter, as well as the maintenance instructions for the O-ring of the Renasys Go. However, the company could not provide documentation of effectiveness checks for these corrective and preventive actions.

Meanwhile, the devicemaker failed to evaluate the impact of decreasing the sensitivity of the leak alarm for the Renasys Go Pump on the device’s risk-assessment records.

Smith & Nephew’s corrective action procedure did not require verification or validation of the CAPA to ensure it is effective and does not adversely affect the finished device, the warning letter says.

The FDA investigator also noted that Smith & Nephew did not use people who represent potential users of the device to perform testing for validation of a change to the canister filter and an updated version of the installation instructions. And the company did not perform a risk-benefit assessment for the individual hazard of exsanguination for negative pressure wound treatment devices, even though this is listed in the risk-assessment record for devices with a final residual risk of “medium.”

Additional citations relate to complaint handling, as the company’s procedure did not require an appropriate statistical methodology to detect recurring quality problems, the letter says. Smith & Nephew had not maintained a section of its procedure that required a risk-assessment review for complaints that are either adverse events or could lead to a potential hazard.

The FDA investigator reviewed 17 complaint records on alleged pooling and/or lack of alarm function for the Renasys EZ/EZ Plus device where the company documented known hazards, finding that 10 did not show a review of the risk assessment for the device.

The FDA also advised the company that certain design enhancements would require new 510(k) clearance, leading Smith & Nephew to temporarily halt commercial distribution of the Renasys product line in the U.S.

“The applications for clearance have now been filed and are awaiting action,” Smith & Nephew said, adding that the company is working with the FDA to address other concerns.

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