Ventlab has received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components.
A supplier to the Grand Rapids, Mich., company failed to inform Ventlab that it did not conform to requirements for washing, drying and lubricating duckbill valves, according to the July 2 warning letter posted online. The valves, which Ventlab uses in manufacturing, have the potential to stick because the drying acts as a secondary cure for the silicone material. The nonconforming material was the subject of a Class 1 recall in May.
Between February 2012 and May 2013, Ventlab received 47 complaints related to duckbill nonconformities and determined that failure to follow the washing/drying process was the root cause. However, duckbill valve complaints received after opening the CAPA “were not fully analyzed to identify other potential causes of the nonconformances,” the warning letter says.
The letter notes that many complaints involved units that had, in fact, been washed and dried. The CAPA was determined effective and closed on Sept. 27, 2013, but Ventlab didn’t evaluate the effectiveness of the corrective actions before closing it.
The letter goes on to say that between May 4 and May 23, 2013, Ventlab received two shipments of patient valves, but not all of the products underwent the wash/dry process. One shipment was not identified as nonconforming product and was used in the manufacture of resuscitator bags without the material review board making a disposition, as required by Ventlab’s SOP for control of nonconforming material.
Meanwhile, the company’s complaint processing procedure lists 13 questions that must be answered for each complaint. But from June 3, 2013, until March 3 of this year, Ventlab received 38 complaints related to stuck duckbill valves in resuscitator bags, and only four records contained the required information.
Ventlab also had not reviewed or updated its risk-management plan for manual resuscitators to account for the potential hazard of device aging and its potential impact on resuscitator valves, the letter adds.
Ventlab did not respond to a request for comment by press time.
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