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

Model Number	2R8875
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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 a clearlink system, solution set leaked from the port of the tubing near the patient.This was observed during medication flush of a tacrolimus iv (intravenous) infusion.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 d9, h3, and h6.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure test and clear passage under water were performed, and it was noted that there was a leak between the assembly of the tubing into the y-site clearlink.It was also noted that the assembly of the tubing into the y-site clearlink was not according to specification.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22358685
• Report Number: 1416980-2025-03555
• Device Sequence Number: 7997544
• Product Code: FPA
• UDI-Device Identifier: 00085412565637
• UDI-Public: (01)00085412565637
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: 2R8875
• Device Catalogue Number: 2R8875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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: TACROLIMUS
• Patient Sex: Unknown