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

Catalog Number	DYND50130
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Yankauer broke in patient's mouth.
Additional Manufacturer Narrative
According to the facility when anesthesia was waking up the patient, they noticed bleeding coming from the patient's mouth.Per the facility a few seconds later the provider noticed more blood coming out of the patient's nose.Upon inspection of the yankauer by provider it was noted the tip of the yankauer was broken off.The provider took out bite block from patient's mouth and performed additional suction and the tip of the yankauer came out of patient's mouth.No additional information is available at this time.The sample was requested for evaluation and the broken device was confirmed.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE
• 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: 21060182
• Report Number: 1417592-2025-00001
• Device Sequence Number: 8023034
• Product Code: JOL
• UDI-Device Identifier: 40080196034957
• UDI-Public: 40080196034957
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/02/2025

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?: Yes
• Device Catalogue Number: DYND50130
• Device Lot Number: 96924050004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/02/2025
• 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: Other
• Patient Sex: Unknown