BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE

    MDR report key: 16448587 · Received February 27, 2023

    Report

    Report Number
    3000223297-2023-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    June 26, 2022
    Report Date
    July 28, 2023
    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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SENT AS A CORRECTION SINCE THE INITIAL MDR SUBMITTED ON 27FEB2023 AND FILED UNDER MANUFACTURER REPORT NUMBER 3000223297-2023-00001, WAS SENT UNDER THE INCORRECT MANUFACTURER REPORT NUMBER (3000223297)- WEST PHARMA. SERVICES IL, LTD. WEST PHARMACEUTICAL SERVICES AZ, INC. (3015176617) IS REGISTERED AS THE LEGAL MANUFACTURER AND SPEC DEVELOPER FOR THE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE. THE CORRECT MANUFACTURER REPORT NUMBER SHOULD BE 3015176617-2023-00001.

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES IL, LTD. (WEST ISRAEL)  INVESTIGATED  A COMPLAINT RECEIVED BY PROGRESSIVE MEDICAL INC.  REGARDING A VIAL2BAG ADVANCED ® 20MM ADMIXTURE DEVICE WHERE THE SPIKE PORTION WAS FOUND TO BE CONTAMINATED.  THE CUSTOMER DID NOT RETURN THE DEVICE TO WEST FOR EVALUATION AS IT WAS DISCARDED BY THE FACILITY.  HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED TO WEST AND VISIBLE CONTAMINATION OF THE DEVICE WAS VERIFIED. ACCORDING TO THE SUPPLIER'S EVALUATION, THE VISIBLE SPOTS ON THE SPIKE WERE DETERMINED TO BE EMBEDDED SPOTS OF DEGRADED PLASTIC MATERIAL (POLYETHYLENE) WHICH OCCURRED DURING THE INJECTION MOLDING PROCESS OF THE CAP (SHIELD).  DEGRADATION OF THE PLASTIC OCCURRED DUE TO HIGH TEMPERATURES OF PLASTICIZATION GROUP OF THE MOLDING MACHINE.  ADDITIONALLY, CONTAMINATED CAPS (SHIELDS) MOST LIKELY RESULTED FROM INSUFFICIENT MAINTENANCE OF THE MOLDS AND MOLDING MACHINE.  CLEANING OF THE MOLDING MACHINE AND PRESENCE OF THE SURFACE STICKY MOLD WERE IMPLEMENTED BY THE SUPPLIER.

    Description of Event or Problem · 0

    ON (B)(6) 2022, PROGRESSIVE MEDICAL, INC. CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT A COMPLAINT FROM A CUSTOMER THAT UPON OPENING A VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE, LOT NUMBER F427, THE SPIKE PORTION WAS FOUND TO BE CONTAMINATED.  IT WAS REPORTED THAT THE DEVICE IS USED FOR UNIT MIXING OF INTRAVENOUS (IV) PIGGYBACKS. TWO OTHER PACKAGES WERE OPENED WITH THE SAME LOT AND EXPIRY DATE AND BOTH WERE VISIBLY CLEAN AND APPEARED UNCONTAMINATED. THE COMPLAINT WAS RE-EVALUATED AND DEEMED AS REPORTABLE BASED ON A CLINICAL IMPACT ASSESSMENT DATE OF (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409311 VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE VIAL2BAG 20MM LHI WEST PHARMACEUTICAL SERVICES AZ, INC. VIAL2BAG ADVANCED®  20MM ADMIXTURE DEVICE F427 10850022888011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown