MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK; FILTER, INFUSION LINE

Model Number	1C8740
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
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 the luer lock adapter of an interlink non-dehp minivolume extension set separated from the tubing.It was observed that the distal end of the ¿cardiac filter tubing¿ remained attached to the patient¿s cvd red lumen while the remainder of the tubing had broken off.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, and h6.H11: the device and a photograph were received for evaluation.The actual device and the returned photograph were visually inspected, and it was noted that there was a separation between the tubing and male luer.The reported condition was verified.The cause of the reported condition could not be determined; however, the possible root cause is related to missing solvent in the tube.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: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25178676
• Report Number: 1416980-2026-01647
• Device Sequence Number: 21508408
• Product Code: FPB
• UDI-Device Identifier: 00085412082028
• UDI-Public: (01)00085412082028(10)DR25H25055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 1C8740
• Device Catalogue Number: 1C8740
• Device Lot Number: DR25H25055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: CVD RED LUMEN
• Patient Sex: Unknown