MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H8480
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
B3/d10: the events occurred during october and november 2025.D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 8 to 10 units of clearlink system non dehp solution sets leaked at the luer connectors.The issue occurred after the line was connected to the non-baxter angio system, where leakage was observed from connector area #9 and the luer connector (#8), with fluid leaking from both the connection interface and the luer connector while the product was in use on a patient and operated with an infusion pump.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK/DUO-VENT
• 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: 24303878
• Report Number: 1416980-2026-00523
• Device Sequence Number: 9679600
• Product Code: FPA
• UDI-Device Identifier: 00085412048499
• UDI-Public: (01)00085412048499
• Combination Product (Y/N): N
• PMA/510(K) Number: K153158
• 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
• Report Date (Section B): 02/10/2026

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: 2H8480
• Device Catalogue Number: 2H8480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/10/2026
• 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: B. BRAUN ANGIO SYSTEM; CATHETER; INFUSION PUMP
• Patient Sex: Unknown