MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCOMP YANK SUCT HNDLE 40; COVERED YANKAUER

Catalog Number	6429
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
Report received of a yankauer soft overmolded tip disengagement related to user error.Reporter stated a 30-year-old male patient who was ventilated through a tracheostomy, was not alert or oriented and was not able to follow commands, bit the yankauer during oral care and the soft overmolded tip disengaged into the patient's mouth.Reporter was unable to confirm if a bite block was in use, however they were able to confirm that the patient bit down on the device.It is unknown how long the yankauer was in use before the event occurred.Staff was able to retrieve the tip with tweezers, and that the patient did not experience any adverse consequences.Although requested, additional information was not provided.Lot information was not provided.The device was returned for evaluation.
Event or Problem Description
The reporter provided lot information for the affected device.
Additional Manufacturer Narrative
The complainant returned the soft over molded tip to aid in the investigation.Lot information was provided.The tip was not attached to any other part of the yankauer device indicating that it disengaged completely from the suction straw.The tip was returned in one piece; however, there did appear to be some damage to the material, likely due to the patient biting on the yankauer.The weld spot was visible inside of the tip indicating that the tip was likely correctly over molded together with the suction straw during manufacturing.A product history review was performed for the affected product code and lot number.All quality checks performed indicated passing results and all release criteria were met per the product drawing.The straw and soft overmold tip products are manufactured at a third-party supplier.The affected lots were inspected by iqa and received passing results for all attributes.The third-party supplier was contacted to make them aware of this complaint.A review of their production and quality records was performed and indicated the affected lots were manufactured to specification.A labelling review was performed.The finished good label for the affected device provides the following warnings: ¿single patient - multiple use.For oral use only.Discard after 24 hours.Do not allow patient to bite down on the oral care tool.Always use a bite block if patient is not alert or cannot follow instructions.Always follow these warnings to prevent a choking or aspiration hazard and to avoid damage to the device." the label also provides the following instructions for use ¿remove yankauer and discard after 24 hours, or according to hospital protocol." additionally, in process quality checks are performed every two (2) hour and could identify defects with the product.The patient bit the device causing the disengagement of the tip.Therefore, it can be concluded that the root cause is related to misuse of the device.

• 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 21702172
• Report Number: 0001419181-2025-00005
• Device Sequence Number: 18142685
• Product Code: JOL
• UDI-Device Identifier: 00618029841353
• UDI-Public: (01)00618029841353(10)99666
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 05/27/2025

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 Catalogue Number: 6429
• Device Lot Number: 99666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 54 KG