inforMED
MalfunctionJOL

FC CC QCARE NONVENT 4X 20

Received Jun 16, 2026 · Event occurred May 19, 2026

Report 0001419181-2026-00016 · MDR key 25522724

Device

Generic name

Covered Yankauer

Manufacturer

Sage Products Llc

Model number

6306-C

Catalog number

6306-C

Lot number

107509

Product problems

  • Material Separation

Patient

28 YR · Male

  • Cough

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 PATIENT WAS NONVERBAL WITH A SEVERE ANOXIC BRAIN INJURY BUT RETAINED THE ABILITY TO COUGH AND RESPOND TO SOME COMMANDS. THE PATIENT WAS OBSERVED TO BE DISTRESSED AND INTERMITTENTLY COUGHING. THE NURSE SUCTIONED THE PATIENT¿S MOUTH AND REPOSITIONED THE PATIENT ONTO THEIR SIDE TO PERFORM A PAD CHANGE. FOLLOWING THIS, THE PATIENT BEGAN COUGHING MORE FORCEFULLY AND WAS REPOSITIONED INTO A HIGH FOWLER¿S POSITION. THE NURSE SUCTIONED THE PATIENT¿S MOUTH AGAIN AND SUBSEQUENTLY OBSERVED A DISENGAGED YANKAUER SOFT TIP IN THE PATIENT¿S MOUTH. THE DISENGAGED TIP WAS REMOVED FROM THE PATIENT'S MOUTH. FOLLOWING REMOVAL, THE PATIENT APPEARED MORE COMFORTABLE, LESS AGITATED, AND THE COUGHING SUBSIDED. NO ADDITIONAL INTERVENTION WAS REQUIRED. A BITE BLOCK WAS NOT USED DURING THIS EVENT. THE REPORTER WAS UNABLE TO CONFIRM WHETHER OR NOT THE PATIENT HAD BITTEN THE DEVICE; HOWEVER, THE NURSE INDICATED THAT BITING WAS NOT DOCUMENTED IN THE NURSING NOTES. THE YANKAUER DEVICE WAS NOT AVAILABLE FOR RETURN ¿ PHOTOS AND LOT INFORMATION PROVIDED.