MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; YANKAUER,BULB TIP,ON/OFF CONTROL,STERILE

Catalog Number	OR164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, during a procedure on (b)(6) 2025 the tip of the yankauer "broke into 2 pieces into the patient" while the doctor was suctioning.The customer reported after the incident occurred "stopped the procedure, irrigated, suctioned and took xrays", and "the patient was under anesthesia longer".The customer reported there was no impact to the patient and the procedure was able to be completed.The customer reported there was no serious injury related to the reported event.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
According to the customer, during a procedure on (b)(6) 2025 the tip of the yankauer "broke into 2 pieces into the patient" while the doctor was suctioning.

• Common Device Name: YANKAUER,BULB TIP,ON/OFF CONTROL,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21942288
• Report Number: 1417592-2025-00209
• Device Sequence Number: 8799739
• Product Code: JOL
• UDI-Device Identifier: 10888277107465
• UDI-Public: 10888277107465
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/01/2025

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: OR164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 98 KG