MAUDE Adverse Event Report: Valmed Srl EVA TPN 500 ML BAG; CONTAINER, I.V.

Catalog Number	FBX1031BP
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2026
Type of Reportable Event	Malfunction

• Brand Name: EVA TPN 500 ML 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: 50112598
• Report Number: 3009128476-2026-00092
• Device Sequence Number: 10320589
• Product Code: KPE
• UDI-Device Identifier: 08056209143293
• UDI-Public: (01)08056209143293(17)300428(10)V2515007
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/07/2026

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
• Device Catalogue Number: FBX1031BP
• Device Lot Number: V2515007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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