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	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were two devices impacted by this issue, referenced within a single complaint.Therefore, two separate mdrs are being submitted to reflect each device.This complaint is currently under investigation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2026, (b)(6) inc.Contacted the manufacturer to report that upon opening the packaging of the vial2bag advanced® 20mm admixture device, a nurse observed that two devices appeared to have debris within their containers.There was no patient involvement and there was no harm reported.

• 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
• MDR Report Key: 24766035
• Report Number: 3015176617-2026-00001
• Device Sequence Number: 18458292
• Product Code: LHI
• UDI-Device Identifier: 10850022888011
• UDI-Public: (01)10850022888011(17)280830(10)L594(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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: L594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/23/2026
• 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