MAUDE Adverse Event Report: Valmed Srl WOLF-PAK IV BAG, 500ML 3-LEG (WLF); CONTAINER, I.V.

Catalog Number	WP-TPNGR500ML
Medical Device Problem Codes	Component Missing (2306); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction

• Brand Name: WOLF-PAK IV BAG, 500ML 3-LEG (WLF)
• 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: 50125415
• Report Number: 3009128476-2026-00087
• Device Sequence Number: 5637203
• Product Code: KPE
• UDI-Device Identifier: 08056209141886
• UDI-Public: (01)08056209141886(17)300928(10)V2530305
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/22/2026

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: WP-TPNGR500ML
• Device Lot Number: V2530305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 08/04/2026
• 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