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

Model Number	2B8012
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 250ml intravia container had a black marking inside the bag.This was observed after compounding with cyclophosphamide.The technician attempted to remove the black marking and realized the marking was inside the bag on the top (embedded).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.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed a black stripe.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.

• 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: 21756408
• Report Number: 1416980-2025-01788
• Device Sequence Number: 9822194
• Product Code: KPE
• UDI-Device Identifier: 00085412003191
• UDI-Public: (01)00085412003191(10)DR24I10024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 2B8012
• Device Catalogue Number: 2B8012
• Device Lot Number: DR24I10024
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown