PATTERSON SALIVA EJECTORS
Received Nov 7, 2019 · Event occurred Sep 11, 2019
Report 9611959-2019-00001 · MDR key 9293336
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON (B)(6) 2019 FOR (B)(6) BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3980. 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 " THEY CAME OFF EASILY. THE OFFICE SAID ONE CAME OFF IN THE PATIENTS MOUTH AND THEY CAUGHT IT BEFORE PATIENT SWALLOWED IT SO THEY CHECKED THE OTHERS AND THEY ALL EASILY SLID OFF." THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4). AN INVESTIGATION WAS CONDUCTED BY THE MANUFACTURING FACILITY. INVESTIGATION: AS NO LOT NUMBER WAS AVAILABLE, THE MANUFACTURING FACILITY CONDUCTED A PRELIMINARY INVESTIGATION OF THE RETAINED SAMPLES OF ALL THE LOTS SUPPLIED TO (B)(6). THE RESULT OF THE PRELIMINARY INVESTIGATION CONCLUDED THAT THE PRODUCT CONFORMS TO SPECIFICATION. NO ROOT CAUSE HAS BEEN IDENTIFIED.
Description of Event or Problem
A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON (B)(6) 2019 FOR (B)(6). BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3980. 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 " THEY CAME OFF EASILY. THE OFFICE SAID ONE CAME OFF IN THE PATIENTS MOUTH AND THEY CAUGHT IT BEFORE PATIENT SWALLOWED IT SO THEY CHECKED THE OTHERS AND THEY ALL EASILY SLID OFF." THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).