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

Model Number	2C4041
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 leaked from bottom of the drip chamber.The issue was further described as, the tubing had a crack and the liquid is leaking from the plastic connection part.This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d4 expiration date (update the null value to n/a), d9, h3, h4, h6, and h11.H11: the device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage under water testing were performed on the sample; a hole in the drip housing assembly was observed.The reported condition was verified.The cause of the condition was determined to be related to sealing process during manufacturing.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.

• Brand Name: NA
• 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: 21064070
• Report Number: 1416980-2024-07787
• Device Sequence Number: 3279080
• Product Code: LJH
• UDI-Device Identifier: 00085412001067
• UDI-Public: (01)00085412001067(10)R24E16116
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown