BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL TRANSFER DEVICE

    MDR report key: 16784659 · Received April 21, 2023

    Report

    Report Number
    3000223297-2023-00004
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    January 12, 2022
    Report Date
    April 21, 2023
    Manufacturer
    WEST PHARMA SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240429
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO OBTAINED PICTURE , THE REPORTED ISSUE WAS VERIFIED. DURING IN PROCESS AS 700 PRODUCTS WERE VISUALLY TESTED, NO ISSUES WERE NOTICED, IN ADDITION A TOTAL OF 1785 PRODUCTS WERE TESTED DURING  IN PROCESS WITH NO ISSUES  NOTICED.  THE BIOLOGICAL CONTAMINATION (HAIR)  WAS A RESULT OF EMPLOYEES, CLOTHES OR FROM THE RAW MATERIAL SUCH AS BLISTER AND TYVEK SUPPLIERS OR MOLDED PARTS, AND HUMAN FACTOR IN PRODUCTION DURING THE ASSEMBLY OR THE SEALING PROCESS.

    Description of Event or Problem · 0

    ON 17-FEB-2022, THE WEST'S CUSTOMER, TAKEDA PHARMACEUTICAL COMPANY LIMITED, CONTACTED WEST IL TO REPORT THAT DURING INCOMING INSPECTION OF MIX2VIAL 20/20MM W/20 M LARGE FILTER TG, THE VISUAL INSPECTION FOUND ONE UNIT CONTAINING A FOREIGN MATERIAL WITHIN THE BLISTER PACKAGE OF THE DEVICE. WEST PHARMA. SERVICES IL, LTD. (WEST ISRAEL)  INVESTIGATED THIS COMPLAINT.  THE DEVICE WAS NOT RETURNED TO WEST IL FOR AN EVALUATION.  HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED TO WEST IL.  THE FOREIGN MATERIAL WITHIN THE BLISTER PACKAGE WAS ANALYZED BY THE CUSTOMER AND CONFIRMED AS HAIR (BIOLOGIC) WHICH WAS IN DIRECT CONTACT WITH THE WEST IL PRODUCT.  THIS WAS FOUND PRIOR TO PATIENT USE.  THE COMPLAINT WAS RE-EVALUATED AND DEEMED AS REPORTABLE BASED ON A CLINICAL ASSESSMENT ON 23MAR2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965432 MIX2VIAL TRANSFER DEVICE MIX2VIAL TRANSFER DEVICE LHI WEST PHARMA SERVICES IL, LTD 8074022 E290 07290108240429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown