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

Model Number	UC8519
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system extension set leaked from "the blue port in the spike" of the tubing.The issue was noticed when hanging the line after spiking the total parenteral nutrition (tpn) bag.The bag was turned upside down and a new device was used to resolve the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, g1, g4, h6, h11.B5: upon additional information, update "clearlink system extension set" to "continu-flo solution set".H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photo sample which observed a set inside a bag; however, a leak could not be identified.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23480490
• Report Number: 1416980-2025-05500
• Device Sequence Number: 16034687
• Product Code: FPA
• UDI-Device Identifier: 00085412486512
• UDI-Public: (01)00085412486512
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: UC8519
• Device Catalogue Number: UC8519
• Device Lot Number: R25F10079
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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: TPN.
• Patient Sex: Unknown