MAUDE Adverse Event Report: West Pharmaceutical Services AZ, Inc. Vial2Bag Advanced 20mm Admixture Device; Set, I.V. Fluid Transfer

Catalog Number	6070030
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: Vial2Bag Advanced 20mm Admixture Device
• Common Device Name: Set, I.V. Fluid Transfer
• Manufacturer (Section D): West Pharmaceutical Services AZ, Inc.; scottsdale AZ 85260
• Manufacturer (Section G): West Pharmaceutical Services AZ, Inc.; scottsdale; AZ 85260
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; +1(484)885-3298
• MDR Report Key: 50222751
• Report Number: 3015176617-2026-00003
• Device Sequence Number: 18726170
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011(17)290227(10)M116(241)36098150(240)6070030
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 6070030
• Device Lot Number: M116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/12/2026
• 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