MAUDE Adverse Event Report: Sage Products LLC QCOMP YANK SUCT HNDLE 40; Covered Yankauer

Catalog Number	6429
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, during oral care suctioning, a healthcare provider utilized a yankauer device and the patient bit down on the device.A bite block was not utilized.It is unknown whether the patient had a history of biting during oral care.As a result, the soft tip completely detached within the patient's mouth and was subsequently ingested.Following ingestion of the detached tip, the patient became tachypneic.Due to the reported ingestion, the patient required sedation and underwent an endoscopic procedure to locate and retrieve the detached soft tip.The tip was identified resting on top of the tracheostomy cuff and was successfully retrieved.No complications were reported during the procedure.Following retrieval, the disengaged soft tip was inspected and confirmed to have been recovered in its entirety.It was reported that the event did not prolong the patient's hospitalization.No additional information regarding the patient's clinical status was available.Although additional information was requested, no further information was received.

• Brand Name: QCOMP YANK SUCT HNDLE 40
• 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: 50182707
• Report Number: 0001419181-2026-00022
• Device Sequence Number: 15917626
• Product Code: JOL
• UDI-Device Identifier: 00618029841353
• UDI-Public: (01)00618029841353(11)260602(10)109130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6429
• Device Lot Number: 109130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown