MAUDE Adverse Event Report: VALMED SRL EVA TPN BAG; CONTAINER, I.V

Model Number	FBX1030BP
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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter exactamix fbx1030bp 250ml eva bag utilized for parenteral nutrition pumping on exactamix compounder has what appers to be thin fibrous material/particulates.This is noticed after pumping and floating in final product.

• Brand Name: EVA TPN BAG
• Common Device Name: CONTAINER, I.V
• Manufacturer (Section D): VALMED SRL; via dell'industria 3; tovo di sant'agata, sondrio 23030 ; IT 23030
• Manufacturer (Section G): VALMED SRL; via dell'industria 3; tovo di sant'agata, sondrio 23030 ; IT 23030
• Manufacturer Contact: greta galli ; via dell'industria 3; tovo di sant'agata, sondrio 23030 ; IT 23030
• MDR Report Key: 21466422
• Report Number: 3009128476-2025-00018
• Device Sequence Number: 8822260
• Product Code: KPE
• UDI-Device Identifier: 08056209143286
• UDI-Public: (01)08056209143286(17)290528(10)V2418003
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: FBX1030BP
• Device Lot Number: V2418003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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