MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD SET,IRRIGATION,4-LEAD,90"; SYSTEM, IRRIGATION, UROLOGICAL

Model Number	DYND19124
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medline tubing kept kinking and interrupted flow of fluids needed for the surgery, extending duration of surgery.

• Brand Name: SET,IRRIGATION,4-LEAD,90"
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; three lakes drive; northfield IL 60093
• MDR Report Key: 16283405
• Report Number: 16283405
• Device Sequence Number: 20028419
• Product Code: LJH
• UDI-Device Identifier: 10080196993833
• UDI-Public: (01)10080196993833(10)18322060001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/25/2023
• Report Date (Section F): 01/25/2023

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 Model Number: DYND19124
• Device Catalogue Number: DYND19124
• Device Lot Number: (10)18322060001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/25/2023