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

Model Number	2N3350
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 an unspecified amount of micro-volume extension sets leaked from an unspecified location.This was observed during setup.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to a1, a2, a3a, a4-a6, b5, b6, b7, d10, h6 (update codes) and h11.A2, a3a, a4-a6, b6, b7, d10: update the null value to n/a.B5: it was further confirmed that that no leakage occurred; however, the issue was being unable to flush during priming, prior to patient connection.There was no patient involvement.No additional information is available.H11: upon receipt of additional information, in the event these devices are unable to be primed, the clinician can choose to replace the device by retrieving a new one, or in the event of an emergency connect a syringe or administration set directly to the catheter.Therefore there is no potential for harm to the patient in the event of inability to prime.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to d4 (lot and udi): update.Additional information: d4: expiration date (update the null value to n/a), h4, h6 (update codes), h11.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• 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: 24506317
• Report Number: 1416980-2026-00834
• Device Sequence Number: 13372087
• Product Code: FPB
• UDI-Device Identifier: 00085412004846
• UDI-Public: (01)00085412004846(17)DR25I09017
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026

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: 2N3350
• Device Catalogue Number: 2N3350
• Device Lot Number: DR25I09017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/01/2026; 04/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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
• Patient Sex: Unknown