MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1C8109
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 the tubing of a solution set became disconnected from the luer lock, resulting in an open system.This occurred during patient infusion at the neonatal intensive care unit.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h4, h6, and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed, and the tubing being separated from the male luer was observed.The reported condition was verified.The cause of the condition could not be determined.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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6(update codes), h11.H11: the device was received for evaluation.Visual inspection was performed which showed that the tubing was separated from the male luer.A lack of solvent was observed during the examination of tubing, and the solvent was not applied uniformly in the tubing.The reported condition was verified.The cause was determined to be due to solvent not being applied uniformly during assembly.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23691889
• Report Number: 1416980-2025-05906
• Device Sequence Number: 9124011
• Product Code: FPA
• UDI-Device Identifier: 00085412031798
• UDI-Public: (01)00085412031798(10)R25B03079(17)270204
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 1C8109
• Device Catalogue Number: 1C8109
• Device Lot Number: R25B03079
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/28/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/30/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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: D10W; IV
• Patient Age: 1 DA
• Patient Sex: Unknown