MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SET; Set, administration, intravascular

Model Number	2N3357
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a micro-volume extension set with 0.2 micrometer filter exhibited air in the line.The issue was identified during a normal saline (ns) flush.The treatment was being administered through a peripheral intravenous (piv) catheter when the infusion pump alarmed for a downstream occlusion.The line and iv site were assessed, and no occlusion was identified.Further evaluation of the medication line filter revealed the presence of air within the filter.The flush was stopped and the medication line was subsequently discarded.There was no report of patient injury or medical intervention associated with these events.No additional information is available at this time.
Additional Manufacturer Narrative
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 NA 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50280757
• Report Number: 1416980-2026-02671
• Device Sequence Number: 10442364
• Product Code: FPA
• UDI-Device Identifier: 00085412639338
• UDI-Public: (01)00085412639338(17)270919(10)DR24I18048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 2N3357
• Device Catalogue Number: 2N3357
• Device Lot Number: DR24I18048
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: Infusion pump; Normal saline (NS) solution; Peripheral intravenous (PIV) catheter
• Patient Sex: Unknown