MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO; STOPCOCK, I.V. SET

Model Number	2C8931
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was added to h6.H11: the actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were reviewed; however, the reported condition of air in the line could not be appreciated through the photographs received.The cause of the reported condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was air entering the line of clearlink continu-flo solution set through the manifold located directly above the stop cock.It was unknown if a patient was connected during this event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: STOPCOCK, I.V. SET
• 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: 23523414
• Report Number: 1416980-2025-05583
• Device Sequence Number: 9613317
• Product Code: FMG
• UDI-Device Identifier: 00085412071725
• UDI-Public: (01)00085412071725
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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,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: 2C8931
• Device Catalogue Number: 2C8931
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/11/2025
• 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
• Patient Sex: Unknown