MAUDE Adverse Event Report: SAGE PRODUCTS LLC CC QCARE NONVENT SOB 20; Covered Yankauer

Model Number	6346
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: CC QCARE NONVENT SOB 20
• Common Device Name: Covered Yankauer
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): Sage Products LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: anansar ituen ; 3909 three oaks road; cary, IL 60013 ; +1(815)455-4700
• MDR Report Key: 25414382
• Report Number: 0001419181-2026-00014
• Device Sequence Number: 21220328
• Product Code: JOL
• UDI-Device Identifier: 50618029831083
• UDI-Public: 50618029831083
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6346
• Device Catalogue Number: 6346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 150 LB
• Patient Race: White