BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE

    MDR report key: 20126114 · Received September 3, 2024

    Report

    Report Number
    3015176617-2024-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 17, 2024
    Manufacturer
    WEST PHARMACEUTICAL SERVICES AZ, INC.
    Product Code
    LHI
    UDI-DI
    10850022888011
    PMA / PMN Number
    K201415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, A PHOTOGRAPH WAS PROVIDED WITH VISIBLE DEFORMITIES AS REPORTED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) NUMBER CORRECTED. COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER. UPON COMPLETION OF THE INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE MANUFACTURER'S CUSTOMER A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 08AUG2024, WEST PHARMA SERVICES DISTRIBUTOR, (B)(4)., CONTACTED WEST PHARMA. SERVICES, IL LTD. (B)(6), TO REPORT THAT UPON OPENING A BOX OF VIAL2BAG ADVANCED¿ 20MM DEVICES, SEVERAL PACKAGES WERE NOT PROPERLY SEALED AND APPEAR TO HAVE GAPS IN THE GLUE. THE CUSTOMER INSPECTED 2 BOXES AND HAS 3 UNOPENED BOXES OF LOT K194 THAT THEY DO NOT WANT TO USE. THE CUSTOMER ALSO NOTED THAT THEY HAVE 61 INDIVIDUAL PACKAGES OF THE SAME LOT. HOWEVER, NOT ALL OF THESE 61 INDIVIDUAL PACKAGES ARE OPENED BY THE CUSTOMER. THE VIAL2BAG DEVICES WERE NOT USED AND THERE WAS NO HARM TO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834165 VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE LHI WEST PHARMACEUTICAL SERVICES AZ, INC. K194 10850022888011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown