PATTERSON SALIVA EJECTORS

Additional Manufacturer Narrative

NO HARM TO THE PATIENT WAS NOTED. AN INVESTIGATION WAS CARRIED OUT BY THE MANUFACTURER, AND A CORRECTIVE ACTION WAS PUT IN PLACE. THE INVESTIGATION CONCLUDED THAT THE CAUSE MAY BE ATTRIBUTED TO THE WELDING DEVICE BEING TEMPORARILY SUSPENDED DURING PRODUCTION. THIS WOULD OCCUR DUE TO THE TRANSITION FROM PRODUCTION OF REMOVABLE CAPS TO PRODUCTION OF SALIVA INJECTOR WITH FIXED CAPS, AND WOULD IMPLY INADEQUATE LINE CLEARANCE.

Description of Event or Problem

A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 14-FEB-2020 FOR PATTERSON DENTAL SUPPLY INC. BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3998. THE SALIVA EJECTOR IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA EJECTORS ARE USED IN DENTISTRY IN ORDER TO REMOVE SALIVA, BLOOD OR OTHER DEBRIS FROM THE MOUTH DURING DENTAL PROCEDURES. THIS DISPOSABLE DEVICE IS CONNECTED TO AN ACTIVE DEVICE, NORMALLY A PNEUMATIC SYSTEM SUCTION CIRCUIT. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED "PINK SALIVA EJECTOR (107-3998) AS THE TIP HAS COME OFF MULTIPLE TIMES. " THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).