FC CC QCARE NONVENT 4X 20
Received Jun 16, 2026 · Event occurred May 20, 2026
Report 0001419181-2026-00017 · MDR key 25522728
Device
Generic name
Covered Yankauer
Manufacturer
Sage Products LlcModel number
6306-CCatalog number
6306-C
Lot number
UNKNOWN
Product problems
- Material Separation
Patient
28 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE YANKAUER TIP DISENGAGED FROM THE DEVICE INTO THE PATIENT¿S MOUTH. THE YANKAUER DEVICE WAS PART OF THE CONTINUE CARE ORAL KIT. THE DISENGAGED TIP WAS REMOVED FROM THE PATIENT'S MOUTH BY THE NURSE. NO FURTHER INTERVENTIONS WERE REPORTED. THE PATIENT WAS REPORTED TO BE NONVERBAL WITH A SEVERE ANOXIC BRAIN INJURY BUT RETAINED THE ABILITY TO COUGH AND RESPOND TO SOME COMMANDS. A BITE BLOCK WAS NOT USED DURING THE EVENT. THE DATE OF THE REPORTED EVENT IS UNKNOWN. NO FURTHER INFORMATION WAS KNOWN BY THE REPORTER. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.