MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Model Number	2C4041
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed, and it was noted that the tubing was incorrectly assembled into the y component due to a twist in the upstream part.Pressure testing and clear passage under water testing were performed, and it was noted that there was a leak observed in the tubing due to the incorrect assembly.The reported condition was verified.The cause of the reported condition was a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a y-type tur/bladder irrigation set was leaking from the tubing at the y shaped component.The leak was observed during preparation at the hospital prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: TUR IRRIGATION SET
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22135408
• Report Number: 1416980-2025-03173
• Device Sequence Number: 20921244
• Product Code: LJH
• UDI-Device Identifier: 00085412001067
• UDI-Public: (01)00085412001067(10)R24E16116(17)290517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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
• Operator of Device: Other
• Device Model Number: 2C4041
• Device Catalogue Number: 2C4041
• Device Lot Number: R24E16116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown