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

Model Number	2N3379
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an interlink system injection site had stress lines.This was observed during visual inspection prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6.H11: the actual device was not available; however, a companion sample was received for evaluation.Visual and functional testing were performed on the companion sample, and there were no issues noted.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: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; street 2; singapore 73777 8; SN 737778
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23066668
• Report Number: 9612057-2025-00080
• Device Sequence Number: 9663298
• Product Code: FPA
• UDI-Device Identifier: 00085412004945
• UDI-Public: (01)00085412004945(10)SR24H21003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K925126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 2N3379
• Device Catalogue Number: 2N3379
• Device Lot Number: SR24H21003
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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
• Patient Sex: Unknown