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	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a covered yankauer soft tip disengagement.The yankauer device is part of the continue care oral kit.Following completion of oral care, the device was removed from the patient¿s mouth and observed to be intact, with no reported issues during use.The separation of the tip occurred during post-use handling while the caregiver was cleaning the device with alcohol pads.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 preceding this event; however, the patient has a history of frequently biting during oral care and a bite block was not used with the affected device.There were no adverse consequences to the patient.No product was returned as the device was discarded.Lot information was provided.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: 25414125
• Report Number: 0001419181-2026-00015
• Device Sequence Number: 9465451
• Product Code: JOL
• UDI-Device Identifier: 00618029831088
• UDI-Public: (01)00618029831088(11)230526(17)240923(10)93165
• 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: Lay User/Patient
• Device Expiration Date: 09/23/2024
• Device Model Number: 6346
• Device Catalogue Number: 6346
• Device Lot Number: 93165
• 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
• Date Device Manufactured: 05/26/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 150 LB
• Patient Race: White