InjuryDYN
PREMIUM¿ SALIVA EJECTORS
Received Feb 13, 2025 · Event occurred Dec 16, 2024
Report 1319130-2025-00001 · MDR key 21379015
Device
Product problems
- Break
- Break
Patient
62 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. USER FACILITY COULD NOT PROVIDE THE LOT NUMBER. THE COMPLAINT DATABASE WAS REVIEWED FOR PART NUMBER ZCW. ZERO COMPLAINTS FOR ZCW HAVE BEEN REGISTERED IN THE DATABASE.
Description of Event or Problem
USER FACILITY REPORTED TO MEDLINE CANADA, CORPORATION THAT DURING PROCEDURE, ANESTHESIA WAS SUCTIONING PATIENT'S MOUTH. WHITE TIP OF SALIVA EJECTOR BROKE OFF. DUE TO THE PATIENT BEING SEDATED, THERE WAS A CONCERN THAT THE TIP COULD BE ASPIRATED. TIP WAS RETRIEVED FROM PATIENT'S MOUTH.