MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. YANKAUER WITH BULB TIP; CATHETER AND TIP, SUCTION

Catalog Number	DYND50130
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Yankauer suction vent, hole in the handle that leaking air, not functioning well when suction.The device sucks through side not tip.

• Brand Name: YANKAUER WITH BULB TIP
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 16610657
• Report Number: MW5115953
• Device Sequence Number: 12299402
• Product Code: JOL
• UDI-Device Identifier: 10080196034956
• UDI-Public: (01)10080196034956
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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
• Device Catalogue Number: DYND50130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown