MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE

Catalog Number	DYND50130
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, during an ent case, "there was a small crack on the top of the suction tip that was not recognized by the surgical team.The surgeon used the suction tip in the throat and the crack in the suction tip caught the uvula and caused a small tear in the uvula.The surgeon was able to cauterize without further issue." the procedure was able to be completed.No additional information 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.
Event or Problem Description
According to the facility, during an ent case, "there was a small crack on the top of the suction tip that was not recognized by the surgical team.The surgeon used the suction tip in the throat and the crack in the suction tip caught the uvula and caused a small tear in the uvula.The surgeon was able to cauterize without further issue.".

• Common Device Name: YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23467281
• Report Number: 1417592-2025-00598
• Device Sequence Number: 21319626
• Product Code: JOL
• UDI-Device Identifier: 10080196034956
• UDI-Public: 10080196034956
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND50130
• Device Lot Number: 25EBF096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG