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

Model Number	2N3339
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two (2) non-dehp t-connector extension sets were loose and leaked.This was observed during a mri procedure on two (2) different patients where propofol was administered.The location of the leak was between the extension sets and intravenous (iv) catheters.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3/d10: the event occurred over two (2) unspecified days.H11: should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, h6 (update codes), h11.H11: one actual device was received for evaluation.Visual inspection observed that the sample was received without the protective tip from the subassembly; instead, it had a syringe attached.A functional pressure test, clear passage under water test and clamp shut-off function were performed; no defects were observed.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 - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22038260
• Report Number: 1416980-2025-02880
• Device Sequence Number: 18207988
• Product Code: FPA
• UDI-Device Identifier: 00085412004747
• UDI-Public: (01)00085412004747(10)UR24K15055
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K921899
• 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): 06/17/2025

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: 2N3339
• Device Catalogue Number: 2N3339
• Device Lot Number: UR24K15055
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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 CATHETER; PROPOFOL
• Patient Sex: Unknown