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

Model Number	1C8740
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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 rubber hub at the y-connector of an interlink non-dehp minivolume extension set was displaced which resulted in a fluid leak.This issue was observed while priming the set prior to patient connection.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction: a1, d4: unique identifier (udi) #, d5.Additional information: d9, h3, h4, h6(update codes), h11.H11: the device was received without its primary packaging for evaluation.Visual inspection of the returned sample identified the incorrect position of the rubber (yellow rubber) at the component y-site.Pressure test was performed on the returned sample, and a leak was observed at the same location (y-site) due to the incorrect position of the rubber.The reported condition was verified.The cause was related to supplier manufacturing process.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 ; 2242702068
• MDR Report Key: 24299174
• Report Number: 1416980-2026-00517
• Device Sequence Number: 9388638
• Product Code: FPB
• UDI-Device Identifier: 00085412082028
• UDI-Public: (01)00085412082028(10)DR25B10031
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: Health Professional
• Device Model Number: 1C8740
• Device Catalogue Number: 1C8740
• Device Lot Number: DR25B10031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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
• Patient Sex: Unknown