MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8378
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During ct with iv contrast administration (not a high-pressure administration) 2 different iv extension set tubes ruptured.Both extensions were from the same lot number.The staff are removing this lot number from the stock.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 23704580
• Report Number: 23704580
• Device Sequence Number: 10691628
• Product Code: FPA
• UDI-Device Identifier: 00085412091792
• UDI-Public: (01)00085412091792(10)R25F14062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025
• Report Date (Section F): 11/19/2025

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
• Device Model Number: 7N8378
• Device Catalogue Number: 7N8378
• Device Lot Number: R25F14062
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/19/2025