PATTERSON SALIVA EJECTORS
Received Feb 16, 2023 · Event occurred Dec 29, 2022
Report MW5115008 · MDR key 16398127
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
Patterson Dental Supply Inc.Catalog number
107-3964
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 3/25/2024 FOR REPORT MW5115008. NEW: REFERENCE MW5115008: THIS IS AN UPDATE TO AN EXISTING MDR TO ADD INFORMATION THAT WAS OBTAINED FOLLOWING THE ORIGINAL SUBMISSION. NEW INFORMATION WILL BE PRECEDED WITH "NEW" TO IDENTIFY NEW INFORMATION BEING ADDED TO THE REPORT. PROBLEM: BLUE SUCTION TIP CAME OFF WHILE AN UNCONSCIOUS PATIENT WAS BEING SUCTIONED. TIP PIECE WAS SAFETY RETRIEVED. MANUFACTURER EVALUATION RESULTS: SINCE THE CUSTOMER HAVEN'T PROVIDED WITH THE LOT NUMBER, NO INVESTIGATION COULD BE CONDUCTED FOR THIS ITEM. HOWEVER, A PREVIOUS SIMILAR ISSUE WAS OBSERVED WITH THIS PRODUCT ON 14-NOV-2022. THE MANUFACTURER PROVIDED AN INVESTIGATION AND A CAPA. THE MANUFACTURER CONFIRMED THAT JUN-2022, AN IMPROVEMENT ACTION WAS CARRIED OUT TO PREVENT THE TIP FROM FALLING OUT FROM THE EJECTOR: A PHOTOCELL HAS BEEN INSTALLED TO MONITOR THE CORRECT APPLICATION OF THE ADHESIVE SUBSTANCE THAT FIXES THE TIP FURTHERMORE, A PNEUMATIC REJECT SYSTEM WAS PUT IN PLACE TO IMPROVE THE REJECTION OF NON CONFORMING CANNULAS.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 4/3/2024 FOR REPORT MW5115008. NEW: REFERENCE MW5115008: THIS IS AN UPDATE TO AN EXISTING MDR TO ADD INFORMATION THAT WAS OBTAINED FOLLOWING THE ORIGINAL SUBMISSION. NEW INFORMATION WILL BE PRECEDED WITH "NEW" TO IDENTIFY NEW INFORMATION BEING ADDED TO THE REPORT. PROBLEM: BLUE SUCTION TIP CAME OFF WHILE AN UNCONSCIOUS PATIENT WAS BEING SUCTIONED. TIP PIECE WAS SAFELY RETRIEVED. MANUFACTURER EVALUATION RESULTS: SINCE THE CUSTOMER HAVEN'T PROVIDED WITH THE LOT NUMBER, NO INVESTIGATION COULD BE CONDUCTED FOR THIS ITEM. HOWEVER, A PREVIOUS SIMILAR ISSUE WAS OBSERVED WITH THIS PRODUCT ON 14-NOV-2022. THE MANUFACTURER PROVIDED AN INVESTIGATION AND A CAPA. THE MANUFACTURER CONFIRMED THAT JUN-2022, AN IMPROVEMENT ACTION WAS CARRIED OUT TO PREVENT THE TIP FROM FALLING OUT FROM THE EJECTOR: A PHOTOCELL HAS BEEN INSTALLED TO MONITOR THE CORRECT APPLICATION OF THE ADHESIVE SUBSTANCE THAT FIXES THE TIP FURTHERMORE, A PNEUMATIC REJECT SYSTEM WAS PUT IN PLACE TO IMPROVE THE REJECTION OF NON CONFORMING CANNULAS.
Description of Event or Problem
BLUE SUCTION TIP OF THE SALIVA INJECTOR CAME OFF WHILE AN UNCONSCIOUS PATIENT WAS BEING SUCTIONED.