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

Model Number	2N3354
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique device identifier (udi) # is based on the di information as no lot number was provided by the reporter.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a micro-volume extension set had a crack on the line located before the lumen attachment site, which resulted in leakage.This occurred during patient infusion with vancomycin medication.Upon returning to flush the line, condensation was observed on the line and there was fluid on the floor.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4, h4, h6 (update codes), h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph showed the device; however, there was no evidence of damage or a leak.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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6(update codes), h11.H11: the device was received for evaluation.During visual inspection the female luer was observed cracked.The reported condition was verified.The cause of the issue could not be determined; however, the most likely cause was due to the user connecting the set to another set while applying a force greater than required.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22089653
• Report Number: 1416980-2025-03037
• Device Sequence Number: 18148129
• Product Code: FPA
• UDI-Device Identifier: 00085412638836
• UDI-Public: (01)00085412638836(10)DR24G19062(17)270722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 2N3354
• Device Catalogue Number: 2N3354
• Device Lot Number: DR24G19062
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 11/14/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/27/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: VANCOMYCIN
• Patient Sex: Unknown