MAUDE Adverse Event Report: WEST PHARMACEUTICAL SERVICES AZ, INC. VIAL2BAG ADVANCED 20MM; SET, I.V. FLUID TRANSFER

Model Number	6070030
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: rn was mixing ordered antibiotic and when secondary tubing was spiked into transfer device it started to leak where the clear plastic piece attaches to the white plastic piece.Medication was wasted and a new vial was prepared, and the same leaking occurred again in the same place.Ref#6070030, lot#l857.Transfer device and packaging placed in biohazard bag and put in anm mailbox in charge office.

• Brand Name: VIAL2BAG ADVANCED 20MM
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): WEST PHARMACEUTICAL SERVICES AZ, INC.; 7400 e. tierra buena ln, ste 1; scottsdale AZ 85260
• MDR Report Key: 25501211
• Report Number: 25501211
• Device Sequence Number: 10539354
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026
• Report Date (Section F): 06/10/2026

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 Model Number: 6070030
• Device Catalogue Number: 6070030
• Device Lot Number: L857
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Date Report Sent to FDA: 06/10/2026