BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE

    MDR report key: 19115714 · Received April 16, 2024

    Report

    Report Number
    3015176617-2024-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 19, 2024
    Report Date
    November 4, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES, LTD. IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT YET BEEN RETURNED TO WEST FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST WITH VISIBLE PARTICLES AS REPORTED INSIDE OF THE PACKAGED DEVICE. UPON COMPLETION OF THE WEST INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE CUSTOMER A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION WAS PERFORMED BY WEST IL. ACCORDING TO WEST IL RECORDS, LOT# J729 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, AND SHIPPED ACCORDING TO SPECIFICATIONS. BATCH RECORDS FOR LOT# J729 WERE REVIEWED AND THERE WERE NO NON CONFORMANCES FOUND. INCOMING INSPECTION FOR PROTECTOR LOT J729 WAS REVIEWED WITH NO ISSUES OBSERVED. 90 RETAINED SAMPLES FROM LOT# J729 WERE INSPECTED VISUALLY, NO ISSUES WERE OBSERVED. NO ADDITIONAL COMPLAINTS WERE RECEIVED AGAINST LOT# J729. ACCORDING TO THE SUPPLIER OF THE PROTECTOR, THE EMBEDDED SPOTS WERE DETERMINED TO BE DEGRADED PLASTIC MATERIAL (POLYETHYLENE) WHICH OCCURRED DURING INJECTION MOLDING PROCESS DUE TO HIGH TEMPERATURES OF PLASTICIZATION GROUP OF THE MOLDING MACHINE. THE RETURNED SAMPLES WERE RECEIVED AT WEST IL, ON (B)(6) 2024 AND WERE INSPECTED. THE RETURNED SAMPLE WAS SENT TO AN EXTERNAL LAB FOR ANALYSIS AND TESTING. ACCORDING TO THE EXTERNAL LAB ANALYSIS, THE MATERIAL ON THE PROTECTORS (SHIELD) WAS DETERMINED TO BE WAX. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED AND OR UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INVESTIGATED A COMPLAINT RECEIVED BY PROGRESSIVE MEDICAL, INC REGARDING ONE (1) OF (B)(4) UNOPENED VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICES DETECTED WITH A FOREIGN DIRT-LIKE SUBSTANCE INSIDE AND ON THE PRIMARY PACKAGING OF THE VIAL2BAG DEVICE. ACCORDING TO THE ENGINEERING EVALUATION, THE PARTICLES OVER THE PROTECTOR (SHIELD) WERE EMBEDDED AND CANNOT BE REMOVED FROM PROTECTOR (SHIELD). ADDITIONALLY, THE ASSEMBLY PROCESS DID NOT CONTAIN WAX, WHICH WAS DETECTED ACCORDING TO AN EXTERNAL LAB ANALYSIS. IT WAS DETERMINED THAT THE PARTICLES ARE RELATED TO THE SUPPLIER AND NOT RELATED TO PRODUCTION PROCESS. A SUPPLIER INVESTIGATION WAS PERFORMED. THE SUPPLIER INVESTIGATION FOUND THAT THE DURING THE MOLDING PROCESS, THE MACHINE OPERATED AT ELEVATED TEMPERATURES. THE ELEVATED TEMPERATURES WERE DUE TO A LACK OF MAINTENANCE OF THE MOLDING MACHINE CAUSING THE PLASTIC MATERIAL TO DEGRADE DURING THE INJECTION MOLDING PROCESS. THIS ISSUE RESULTED IN THE FORMATION OF EMBEDDED SPOTS OF DEGRADED PLASTIC MATERIAL IN THE PROTECTORS. THE MANUFACTURER WILL IMPLEMENT CORRECTIVE ACTIONS TO IMPROVE THE DETECTABILITY INCLUDING VISUAL SORTING OF THE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICES PRIOR TO RELEASE FOR PRODUCTION. UNIQUE DEVICE IDENTIFIER (UDI) NUMBER CORRECTED.

    Description of Event or Problem · 0

    ON 20MAR2024, (B)(6). CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT THAT ON 19MAR2024, A MATERIALS MANAGER AT A HOSPITAL NOTICED THAT ONE OF THE UNOPENED VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE BLISTER PACK APPEARED TO HAVE A FOREIGN DIRT-LIKE SUBSTANCE INSIDE OF IT AND ON THE VIAL2BAG DEVICE. THE PRODUCT WAS NOT OPENED, NOR WAS IT USED. THERE WAS NO HARM TO ANY PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690968 VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE LHI WEST PHARMACEUTICAL SERVICES AZ, INC. J729 10850022888011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown