450 SAL EJECTOR 3283
Received Apr 16, 2020 · Event occurred Apr 5, 2020
Report 9612030-2020-02451 · MDR key 9967168
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
CovidienModel number
8881450004Catalog number
8881450004
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.
Description of Event or Problem
THE CUSTOMER REPORTED THAT RIGHT AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP DROPPED INTO THE PATIENT'S MOUTH. THE CAP WAS ABLE TO BE REMOVED IMMEDIATELY FROM THE PATIENT'S MOUTH AND THERE WAS NO ADDITIONAL TREATMENT NEEDED.