inforMED
MalfunctionJOL

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 Llc

Model number

6306-C

Catalog 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.