MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTRAVIA; CONTAINER, I.V.

Model Number	2B8014
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After competition of mixing oritavancin technician noticed a floater in the bag ( looks like a a string).Alerted pharmacist.Medication was remade.Empty bag baxter ( ntravia 1000 ml container was used.Lot dr23e10079, 2b8014.

• Brand Name: INTRAVIA
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 23778940
• Report Number: 23778940
• Device Sequence Number: 13280856
• Product Code: KPE
• UDI-Device Identifier: 00085412000046
• UDI-Public: (01)00085412000046
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2025
• Report Date (Section F): 11/25/2025

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
• Device Model Number: 2B8014
• Device Catalogue Number: 2B8014
• Device Lot Number: DR23E10079
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/25/2025