MEDICOM SAFEBASIC SALIVA EJECTORS

Additional Manufacturer Narrative

AN INVESTIGATION WAS CONDUCTED AT THE MANUFACTURING FACILITY. 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 (B)(6) 2019 FOR MEDICOM SAFEBASICS SALIVA EJECTOR. ITEM CODE 700 LOT# 20181426. THE SALIVA EJECTOR IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA EJECTORS ARE USED IN DENTRISTRY 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 " THE BLUE TIPS ARE POPPING OFF IN PEOPLE'S MOUTHS AND THE TIPS ARE EVEN OFF THE SALIVA EJECTORS IN THE BAGS." THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).