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

Model Number	2C8419
Medical Device Problem Codes	Crack (1135); Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
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 luer lock of three (3) clearlink system solution sets broke and medication leaked; the outer rim of the luer lock was cracked.The issue was identified during continuous infusion of propofol.The event was further described as leaking "between luer lock at end of tubing set and the needleless connector on a central line/three way stopcock".Each time, the nurse found the tubing was disconnected from an unspecified needleless connector.When attempting to reconnect, the nurse was unable to due to the identified crack.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6 (update codes), h11.H4: the lot was manufactured between 08/18/2025 - 08/19/2025.H11: one (1) device was received for evaluation.Visual inspection was performed which showed that the two-piece luer lock was broken.The reported condition was verified.The cause of the issue 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.

• 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 ; 2242702068
• MDR Report Key: 24119232
• Report Number: 1416980-2026-00285
• Device Sequence Number: 9334934
• Product Code: FPA
• UDI-Device Identifier: 00085412048956
• UDI-Public: (01)00085412048956(10)R25H16123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112893
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 2C8419
• Device Catalogue Number: 2C8419
• Device Lot Number: R25H16123
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CATHETER (CENTRAL LINE); PROPOFOL; THREE-WAY STOPCOCK; UNSPECIFIED NEEDLELESS CONNECTOR
• Patient Sex: Unknown