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

Model Number	2N3350
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 two (2) micro-volume extension sets leaked at the filter prior to therapy.A syringe was used to prime the tubing.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6 (update codes), h11.H11: three (03) actual devices and two (02) photographs were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A pressure test was performed and a leak was observed in the air vent of the filter in one of the returned samples.The reported condition was verified in one of the samples.The cause of the condition could not be determined.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: NA
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22047194
• Report Number: 1416980-2025-02913
• Device Sequence Number: 8782155
• Product Code: FPB
• UDI-Device Identifier: 00085412004846
• UDI-Public: (01)00085412004846(10)DR24L06079(17)291231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/20/2025

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: 2N3350
• Device Catalogue Number: 2N3350
• Device Lot Number: DR24L06079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sex: Unknown