A devicemaker’s manufacturing facility in Oregon was cited for closing customer complaint investigations without documenting the changes identified for addressing the issues or verifying their effectiveness.
An FDA investigator reviewed eight complaints of Dental Components’ distributed medical devices during a September 2017 site inspection and found that four of them listed corrective actions, but their effectiveness had not been documented. Issues reported in the complaints include a barb coming out of the Autoclavable Premium Saliva Ejector swivel assembly, and threaded tips not screwing off.
The facility also lacked certain adverse event reporting procedures and requirements. It had not specified situations that would reasonably suggest a device malfunction would be likely to cause or contribute to a death or serious injury if it were to reoccur, as well as requirements for ensuring timely MDR submissions to the FDA. Out of the eight closed complaints, five had not been evaluated to determine whether they met the criteria as MDR-reportable events.
The agency also found deficiencies in the firm’s procedures for maintaining device history records. A total of 11 records out of 13 selected did not include required information, including initials and dates, from personnel who released the devices for distribution.