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

Model Number	7N8300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During piv [peripheral intravenous line] insertion the catheter extension set was found defective.Unable to flush or draw blood from it.Almost pulled iv out thinking it hit a valve when i decided to remove extension and try to flush.That's when observed that the adapter on the device is defective.New catheter extension placed.Product baxter one-link non-deph microbore catheter extension set (b)(4), lot (10) ur25f040245.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 24477514
• Report Number: 24477514
• Device Sequence Number: 10212666
• Product Code: FPA
• UDI-Device Identifier: 00085412091839
• UDI-Public: (01)00085412091839
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2026
• Report Date (Section F): 02/24/2026

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
• Device Model Number: 7N8300
• Device Catalogue Number: 7N8300
• Device Lot Number: UR25F04024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/24/2026