MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE Q4 SYS W/PROX 20; COVERED YANKAUER

Model Number	6804
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Report received of a covered yankauer soft overmolded tip disengagement due to biting.Reportedly, a 42-year-old male patient with a history of cerebral palsy was admitted to the medical-surg unit at the facility on an unknown date with an admitting diagnosis of (respiratory syncytial virus) rsv.On (b)(6) 2026, a family member at bedside used the covered yankauer to attempt to suction the patient's mouth.A bite block was not in use.The patient bit down on the yankauer tube, behind the tip.The patient's family member attempted to pull the yankauer out of the patient's mouth.Eventually, the patient did open their mouth and the yankauer was removed.The patient then began to experience, increased heart rate, blood pressure and coughing.Staff then noticed that the tip was no longer attached to the yankauer and determined that the patient had aspirated the tip.The patient was transferred to the icu, sedated and administered a paralytic.He was intubated and a bronchoscopy was performed.The disengaged tip of the device was located in the patient's right mainstem bronchus and removed.The patient recovered from sedation and was extubated without issue.The patient did not experience any other adverse consequences or sequalae related to this event.The affected device and packaging were discarded.The reporter provided lot information for devices of the same product code in the supply area at the time of the event and returned a sample from this lot for evaluation.Although requested, no additional information was available.
Additional Manufacturer Narrative
The affected device was discarded.The complainant provided lot information for devices of the same product code in the supply area at the time of the event and returned a sample from this lot for evaluation.The complainant provided a photo from the bronchoscopy that showed the disengaged yankauer tip in the patient's lung before removal.No other photographs were provided.A visual/functional inspection on the returned device was performed.No signs of damage or defects were observed, and the soft over molded tip was securely attached to the device.The straw and soft overmolded tip components are supplied by a third party manufacturer and were inspected at incoming quality assurance prior to being used in the manufacturing process.The inspection for the returned device¿s lots indicated passing results for all attributes.A product history review was performed for the returned product code and lot.Per the product history record, all quality checks performed indicated passing results and all release criteria were met per the product drawing.A labeling review was performed.The directions state: ¿use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands." it was determined that the root cause of the covered yankauer soft overmolded tip disengagement was due to the patient biting on the device.Complaints related to yankauer tip disengagement will continue to be monitored and trended.

• Brand Name: QCARE Q4 SYS W/PROX 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 24778654
• Report Number: 0001419181-2026-00010
• Device Sequence Number: 6134580
• Product Code: JOL
• UDI-Device Identifier: 00618029841216
• UDI-Public: (01)00618029841216(11)250707(17)270420(10)104067
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6804
• Device Catalogue Number: 6804
• Device Lot Number: 104067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male