MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8378
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at least two one-link non-dehp standard bore catheter extension sets split open and resulted in leak during iv contrast injection.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
This report reflects patient information and event details received by the fda in the form of medwatch report mw5187297.Therefore, additional information was added to a2, a3, a4, a5, b5, d10, and h10; as well as correction to clinical and health effect impact codes.
Event or Problem Description
It was reported that a one-link non-dehp standard bore catheter extension sets split open during iv contrast injection, resulting in leakage.A patient presented for a ct scan with iv contrast.The iv line was prepared and tested prior to the exam following the standard protocol, including sterilization of the iv hub with alcohol swab followed by a saline flush.The saline flush was confirmed to be patent and functioning appropriately, and the scan proceeded.Iodinated contrast injection was initiated without any issues.Injection monitoring indicated normal pressure values throughout contrast delivery.However, during the subsequent saline flush, a sudden spike in pressure was observed on the injector system.Upon assessment, the iv tubing was observed to have split.It was confirmed that the iv line was not clamped and no kinks were present.The residual saline from the injection was observed on surrounding surfaces, and blood was noted to exit from the split tubing.The tubing was clamped to stop the leakage.It was further confirmed that there was no iv extravasation and that the iv remained patent and functional.The extension set was replaced, and the iv remained in use.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 h4, h6, and h11.H11: the actual device was not available; however, a two (2) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage testing were performed, and no defects were observed.The reported condition was not verified.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: ONE-LINK
• 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: 25192607
• Report Number: 1416980-2026-01672
• Device Sequence Number: 10110338
• Product Code: FPA
• UDI-Device Identifier: 00085412091792
• UDI-Public: (01)00085412091792(10)R26B25178
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• 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,Followup
• Report Date (Section B): 06/19/2026

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: Other
• Device Model Number: 7N8378
• Device Catalogue Number: 7N8378
• Device Lot Number: R26B25178
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 06/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/05/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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: CT SCAN; IODINE CONTRAST INJECTION; IV CONTRAST INJECTION
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic