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

Model Number	2N3354
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a micro-volume extension set had a crack resulting in a leak near the connection point to a non-baxter connector.This was observed during device use, when hanging a flush for medication (piperacillin/tazobactam).It was further described as "crack at top of syringe line where we attach a cap".There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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.
Additional Manufacturer Narrative
Additional information: h6 (update codes), h11.H11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph showed evidence of being "wet" near the connection point; however, the crack cannot be identified.The reported leak was verified.The cause of the leak could not be determined.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; 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: 22610235
• Report Number: 1416980-2025-03900
• Device Sequence Number: 18532989
• Product Code: FPA
• UDI-Device Identifier: 00085412638836
• UDI-Public: (01)00085412638836
• 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
• Report Date (Section B): 08/29/2025

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: 2N3354
• Device Catalogue Number: 2N3354
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ICU MEDICAL MICROCLAVE CLEAR NEUTRAL CONNECTOR.; PIPERACILLIN/TAZOBACTAM.
• Patient Sex: Unknown