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	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a unspecified quantity of micro-volume extension sets with 0.2 m filter were leaking 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 was no report of patient injury or medical intervention associated with these events.No additional information is available at this time.
Additional Manufacturer Narrative
D4 udi: as the lot # is unknown, the udi will consist of the primary di number only.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6, and h11.H11: the device and a video of the sample were received for evaluation.A visual inspection was performed to the actual sample received, and all components were correctly placed and according to the specification.No visual defects were observed in this unit.The sample was then submitted to pressure testing, and a leak was not observed.In addition, the sample was submitted to clear passage testing, and no blockage was detected.The returned video was reviewed, and it was noted that there was a leak from the filter vent hole.The reported condition was verified in the video sample.The cause of the reported condition could not be determined.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: 25417142
• Report Number: 1416980-2026-01934
• Device Sequence Number: 13150665
• Product Code: FPB
• UDI-Device Identifier: 00085412653297
• UDI-Public: (01)00085412653297
• 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): 07/07/2026

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: Other
• Device Model Number: 2N3382
• Device Catalogue Number: 2N3382
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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