MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; YANKAUER,FLEXIBLE HANDLE,REGLR CAPACITY

Catalog Number	OR61
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	12/24/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 there was a delay in suctioning the patient as the yankauer wouldn't "properly connect to the suction tubing".Per the facility the device was being used "in preparation for intubation" and "yankauer was connected to suction tubing and suction turned on then placed at head of bed".Per the facility the device was tested prior to use and the suction was "turned to highest setting for max suction".Per the facility the "patient aspirated, required bronchoscopy to remove aspirated material".Per the facility the patient has expired.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Multiple lot numbers were provided by the facility and were listed as: 10001, 30001, 40001.
Event or Problem Description
According to the facility on (b)(6) 2024 there was a delay in suctioning the patient as the yankauer wouldn't "properly connect to the suction tubing".

• Common Device Name: YANKAUER,FLEXIBLE HANDLE,REGLR CAPACITY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21211647
• Report Number: 1417592-2025-00031
• Device Sequence Number: 3942744
• Product Code: JOL
• UDI-Device Identifier: 40884389100012
• UDI-Public: 40884389100012
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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
• Device Catalogue Number: OR61
• Device Lot Number: 10001, 30001, 40001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 93 KG