MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION. INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2N3328
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
T-connector directly connected to the picc [peripherally inserted central catheter] has a visible, slowly leaked ivf [intravenous fluids].

• Brand Name: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 24229420
• Report Number: 24229420
• Device Sequence Number: 15698427
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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: 2N3328
• Device Catalogue Number: 2N3328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026