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

Model Number	2C6255
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified quantity of clearlink continu-flo solution sets had trouble connecting to a non baxter intravenous (iv) catheter which resulted in disconnection and fluid leakage.During iv setup, it was observed that there were repeated difficulties connecting sets to iv catheters.The luer lock spinner on the sets would not properly thread onto the catheter hub and appeared stripped or unable to secure a tight connection.It was attempted to connect sets from three separate packages to an iv catheter.In each case, the tubing could not be secured.A syringe was able to attach to the catheter without difficulty, suggesting the issue was associated with the sets rather than the catheter.In addition to this occurrence, there have been at least four similar instances over the previous two weeks in which iv tubing either could not be threaded onto the catheter or appeared to be connected but subsequently leaked.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: d4.D4: expiration date: na.D4: unique identifier (udi): (b)(4).Additional information: h4, h6(update codes), h11.H11: the actual device was not available; however, a photograph was provided for evaluation.The actual device is not visible in the provided picture; therefore, a device analysis could not be completed.Furthermore, the reported condition could not be confirmed nor refuted.The cause of the condition 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/CONTINU-FLO
• 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: 25154081
• Report Number: 1416980-2026-01608
• Device Sequence Number: 9212896
• Product Code: FPA
• UDI-Device Identifier: 00085412046310
• UDI-Public: (01)00085412046310(17)310204(10)R26B03093
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• 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): 06/09/2026

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: 2C6255
• Device Catalogue Number: 2C6255
• Device Lot Number: R26B03093
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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: CATHLON IV CATHETER
• Patient Sex: Unknown