MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SET; FILTER, INFUSION LINE

Model Number	2N3382
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 with 0.2 m filter leaked from the air venting mechanism.The process step at which the issue occurred was not specified.It was stated that users manually prime the lines, occasionally using syringes smaller than 10ml.There were no reports of patient injury or medical intervention associated with these events.No additional information is available at this time.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, h6, and h11.H11: the device and a video of the sample were received for evaluation.Visual inspection on the actual sample did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage testing were performed on the actual sample, and no signs of a leak or blockage were observed from the device.Based on the video evidence, the reported condition was considered verified.The reported condition was verified in the video sample.The customer reported occasional use of syringes smaller than 10 ml.The cause could not be determined; however, based on the available information, the most probable cause of the condition was determined to be related to use conditions.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: EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• 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 ; 2242705355
• MDR Report Key: 25338353
• Report Number: 1416980-2026-01828
• Device Sequence Number: 17484979
• Product Code: FPB
• UDI-Device Identifier: 00085412653297
• UDI-Public: (01)00085412653297(17)270822(10)DR24H21055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 2N3382
• Device Catalogue Number: 2N3382
• Device Lot Number: DR24H21055
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: IV PUMP; UNSPECIFIED MEDICATION
• Patient Sex: Unknown