MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK/CONTROL-A-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C6891
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that four (4) interlink system extension sets had issues during patient use.The regulator was observed to be leaking on three instances.The lines were observed to be filled with blood on two occasions.Additionally, when an iv flush was administered at the injection site, the regulator broke on two instances.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6) should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h4, h6(update codes), h11.H11: the actual device was not available; however, five photographs of the sample were provided for evaluation.Visual inspection was performed on all the photo samples.One of the images showed that the assembly had all its components, no other crack or damage was visible; however, the regulator was detached.The backflow from tube to the regulator connection has no return components, the assembly was horizontal and below the patient's hand.The reported condition was verified.The cause of the issue could not be determined: however, the probable cause is use-related.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/CONTROL-A-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24717629
• Report Number: 1416980-2026-01096
• Device Sequence Number: 6088363
• Product Code: FPA
• UDI-Device Identifier: 00085412002422
• UDI-Public: (01)00085412002422(10)DR25L05024
• Combination Product (Y/N): N
• PMA/510(K) Number: K121634
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 2C6891
• Device Catalogue Number: 2C6891
• Device Lot Number: DR25L05024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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: IV FLUSH.
• Patient Sex: Unknown