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

Model Number	1C8109
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was added to h4, h6 and h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection identified a cut or hole in the tubing.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
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a solution set leaked from the tubing below the drip chamber; solution squirted out of the line due to a hole.This was observed during priming with zinecard.A new bag was remade to continue preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6, and h11.H11: the device was received for evaluation.Visual inspection on the actual sample did not identify any abnormalities that could have contributed to the reported condition.Pressure testing was performed, and a leak was identified in the tube due to a cut in the tube.The reported condition was verified.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 ; 2242705355
• MDR Report Key: 25236921
• Report Number: 1416980-2026-01719
• Device Sequence Number: 18573251
• Product Code: FPA
• UDI-Device Identifier: 00085412031798
• UDI-Public: (01)00085412031798(10)R25K17062(17)271118
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: Health Professional
• Device Model Number: 1C8109
• Device Catalogue Number: 1C8109
• Device Lot Number: R25K17062
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 06/24/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/22/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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
• Patient Sex: Unknown