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

Model Number	2N3348
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 three (3) units of non-dehp micro-volume extension sets leaked during patient infusion with packed red blood cells (prbc's).The issue was described as follows; a newly inserted parenteral intravenous (piv) line was flushed with 3mls of saline before the infusion began.Fifteen minutes after starting the transfusion, blood was found in the patient¿s bed.The infusion was paused and the iv line was flushed without any issue.The unspecified infusion pump did not alarm for occlusion as the blood was leaking from the connection site.The tubing was replaced and primed.When the transfusion was restarted, blood leaked again from the connection between the tubing and the t piece.The connection was taken apart, cleaned, and reconnected; however, the blood continued to leak.A third tubing was primed with saline and showed no issues.However, the leak reoccurred once the transfusion resumed.The tubing was then replaced with a set from a different lot and the transfusion ran smoothly with no leaks at the piv connection site.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, h6(update codes), h11.H11: the actual devices were not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph showed the top web (printed side) of the primary packaging.The reported issue of 'leak' could not be confirmed from the photo sample.The reported condition was not verified.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: MICRO-VOLUME
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd. 721, km. 0.3; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24444828
• Report Number: 1416980-2026-00722
• Device Sequence Number: 18754084
• Product Code: FPA
• UDI-Device Identifier: 00085412004822
• UDI-Public: (01)00085412004822(10)UR25H27017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811078
• 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
• Report Date (Section B): 03/31/2026

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: 2N3348
• Device Catalogue Number: 2N3348
• Device Lot Number: UR25H27017
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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: PIV; PRBC; T CONNECTOR; UNSPECIFIED INFUSION PUMP
• Patient Sex: Unknown