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

Model Number	2C4040
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at least three (3) (between 3 and seven (7)) cysto/bladder irrigation sets leaked.The location was further specified as leaking from where "the tubing connected to the spiking port" or water leaking from "the bottom of the drip chamber where the tubing connects to the drip chamber"; there was no medication loss.This occurred during a hysteroscopy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6, h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed which showed the leak location between the components housing and the tubing.The reported condition was verified.The cause of the issue could not be determined.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: 21645573
• Report Number: 1416980-2025-01288
• Device Sequence Number: 18048600
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 2C4040
• Device Catalogue Number: 2C4040
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: WATER
• Patient Sex: Unknown