CC QCARE NONVENT SOB 20

Description of Event or Problem

REPORT RECEIVED ON 05/07/2026 OF A COVERED YANKAUER SOFT TIP DISENGAGEMENT. APPROXIMATELY TWO YEARS AGO - ESTIMATED EVENT DATE (B)(6) 2024 - WHILE A HEALTHCARE PROVIDER ADMINISTERED ORAL CARE, 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 HAD ADVANCED ALZHEIMER¿S DISEASE AND HIGH SECRETION LEVELS REQUIRING FREQUENT SUCTIONING, TYPICALLY AT LEAST EVERY HOUR. IT WAS NOTED THAT WHEN THE EVENT OCCURRED THE DEVICE HAD BEEN IN USE FOR 2-3 DAYS. THE REPORTER COULD NOT CLARIFY IF THE PATIENT BIT THE DEVICE DURING THIS EVENT; HOWEVER, THE PATIENT HAS A HISTORY OF FREQUENTLY BITING DURING ORAL CARE AND A BITE BLOCK WAS NOT USED DURING THIS EVENT. FOLLOWING THE DISENGAGEMENT, THE NURSE IMMEDIATELY REMOVED THE DISENGAGED YANKAUER TIP FROM THE PATIENT'S MOUTH. NO FURTHER INTERVENTION WAS REQUIRED, AND PATIENT DID NOT EXPERIENCE A SERIOUS INJURY. NO PRODUCT WAS RETURNED AS IT WAS DISCARDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.