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

Model Number	2J8003
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	11/21/2025
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 at least one non-dehp fluid path intravia container had debris inside the bag, upon closer inspection it appeared to be a round piece of plastic floating in the bag.The issue was noticed while preparing a dose of medication.A new dose was prepared to resolve the issue.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: b5, d4 expiration date (update to n/a), d9, h3, h4, h6 (update codes), h11 b5: the event was observed with one (1) device.The bag was spiked with a non-baxter continuous ambulatory delivery device (cadd) intravenous (iv) line.The bag contained blinatumomab.H11: the actual device and photograph of the sample were provided for evaluation.Visual inspection of the photo sample identified several particulates; however, the material of these particles was unknown.Visual inspection of the returned sample identified particles inside the fluid flow of the bag.The reported condition was verified.The cause of the issue 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: 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 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23927214
• Report Number: 1416980-2025-06247
• Device Sequence Number: 9013377
• Product Code: KPE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 2J8003
• Device Catalogue Number: 2J8003
• Device Lot Number: DR25E21024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 09/16/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/02/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown