MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA; CONTAINER, I.V.

Model Number	2B8013
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an empty 500 ml capacity intravia container had particulate in the solution.The particulate was a large solid white plastic looking particulate.The particulate best matched the interior surface of the bag septum.This was observed prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h4, h6, and h11: h11: the actual device was not available; however, photographs of the sample were provided for evaluation.A visual inspection was performed, and a little particle in the bag was observed.The reported condition was verified.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.
Additional Manufacturer Narrative
Additional information was added to h11: h11: the ir spectrum of the particles best matches the interior surface of a baxter intravia bag septum at approximately 88.8%.It is likely that this pm comes from the membrane in the administration port of the bag.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: h6 (codes for investigation findings and investigation conclusions were corrected).Additional information was added to h11: the device analysis was performed by a non-baxter lab.The cause of the issue was due to material supplier related to manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTRAVIA
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; 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: 22023299
• Report Number: 1416980-2025-02851
• Device Sequence Number: 8734050
• Product Code: KPE
• UDI-Device Identifier: 00085412035260
• UDI-Public: (01)00085412035260(10)DR24E31055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 2B8013
• Device Catalogue Number: 2B8013
• Device Lot Number: DR24E31055
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 02/19/2026; 02/19/2026
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/18/2025; 02/26/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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