MAUDE Adverse Event Report: VALMED SRL TPN EVA BAG 3000ML WITH FEMALE CONNECTOR; CONTAINER, I.V.

Catalog Number	FBX1034BP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the analysis of the received sample, it is evident that there is a small hole on the side of the bag from which liquid leaks once the bag is filled.The root cause is attributable to non-compliant equipment, in particular the plates used for the leak test, which do not meet valmed standards, as well as to the lateral, rather than perpendicular, method used to remove the bags from the plates.A previous investigation conducted on the manufacturing process of the third-party supplier revealed that the plates used for the leak test were not compliant with valmed standards.Specifically, the spacers were not correctly positioned, and, in addition, it was observed that the operator occasionally removed the bags from the plates using a lateral movement rather than a perpendicular one.This removal method, combined with the non-compliance of the plates, may have caused tearing of the material.Although these bags passed the leak test, as no immediate leakage was detected, the presence of micro-tears may evolve into actual holes during subsequent processing steps or over time, thereby compromising product integrity.After analyzing the sample, the previously conducted analysis is confirmed.A corrective action was opened concerning the replacement of the plates used to perform the leak test at the third-party supplier starmec, as they were manufactured according to standards defined by valmed.The corrective action was closed with a positive outcome on 14/10/2025.It is considered effective, as no similar complaints regarding batches produced after the implementation of the corrective action have been reported to valmed.
Event or Problem Description
Baxter 3 liter eva tpn bags found leaking on multiple occasions.After completing compounding bag was place on counter to be picked up and noted to be leaking in upper corner near handle.This has happened 3 times.

• Brand Name: TPN EVA BAG 3000ML WITH FEMALE CONNECTOR
• 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: 24649354
• Report Number: 3009128476-2026-00025
• Device Sequence Number: 13210686
• Product Code: KPE
• UDI-Device Identifier: 08056209143323
• UDI-Public: (01)08056209143323(17)290728(10)V2421501
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 Catalogue Number: FBX1034BP
• Device Lot Number: V2421501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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