MAUDE Adverse Event Report: Fenwal International Inc. Transfer Pack; Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path

Model Number	4R2014
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fever (1858); Hypoxia (1918); Chills (2191)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: Transfer Pack
• Common Device Name: Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
• Manufacturer (Section D): Fenwal International Inc.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer (Section G): Fenwal International Inc.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; +1(847)550-2300
• MDR Report Key: 50948061
• Report Number: 3004548776-2026-00409
• Device Sequence Number: 13374806
• Product Code: KSR
• UDI-Device Identifier: 10811137010544
• UDI-Public: 10811137010544
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4R2014
• Device Catalogue Number: 4R2014
• Device Lot Number: FA26D23020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown