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

Model Number	2N3328
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	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing of an interlink non-dehp extension set separated from the y-site.This issue was described as a break in the line as the y tubing bottom became completely detached.The separation of the bonded components resulted in a leak.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 address (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), d9, h3, h4, h6 (update codes), h11.H11: the samples and photo were received inside a biohazard plastic bag with an absorbent pad for evaluation.However, two (2) used units and one (1) open package of reported product was received.Visual inspection was performed on the received units and photo samples.It was observed that the received units do not correspond to the code reported.Only the packaging received corresponds to the code and lot reported.The reported condition was verified.The cause of the condition could not be determined.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.
Additional Manufacturer Narrative
Correction: h6(update codes), h11.H11: no photo or actual alleged device was returned; therefore, a device analysis could not be completed, and no verification of the reported problem was available for this set.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: 22152481
• Report Number: 1416980-2025-03203
• Device Sequence Number: 7957588
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662(10)UR24I20277
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: Other
• Device Model Number: 2N3328
• Device Catalogue Number: 2N3328
• Device Lot Number: UR24I20277
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/21/2025; 09/17/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/03/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2024
• 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: NI.
• Patient Age: 1 MO
• Patient Sex: Unknown