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

Model Number	2B8012
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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intravia container contained particulate matter inside the solution/fluid path.The particulate matter was described as 'very fine, almost hair-like' material floating within the solution.The issue was observed during setup after sterile water for injection, dextrose 50% vial, sodium chloride 4 meq/ml intravenous solution, and heparin (pf) 100 unit/ml were added for a neonatal custom intravenous infusion.The bag was quarantined and a new bag was compounded to resolve the issue.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
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; parque industrial itabo; carretera sanchez km 18 1/2; haina NA 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50766681
• Report Number: 1416980-2026-02958
• Device Sequence Number: 18529306
• Product Code: KPE
• UDI-Device Identifier: 00085412003191
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K964853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 2B8012
• Device Catalogue Number: 2B8012
• Device Lot Number: DR25I16062
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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