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

Model Number	7N8378
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the events occurred in november 2025.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of two (02) one-link non-dehp standard bore catheter extension sets ruptured.This occurred during computed tomography with intravenous (iv) contrast administration.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction: this report is a duplicate of manufacturer report number 1416980-2025-06146.All information can be found under manufacturer report number 1416980-2025-06146.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 ; 2242702068
• MDR Report Key: 23934204
• Report Number: 1416980-2025-06254
• Device Sequence Number: 5739251
• Product Code: FPA
• UDI-Device Identifier: 00085412091792
• UDI-Public: (01)00085412091792(10)R25F14062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: R25F14062
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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: IV CONTRAST
• Patient Sex: Unknown