BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED VIAL ADAPTER 20MM

    MDR report key: 25242774 · Received May 21, 2026

    Report

    Report Number
    3000223297-2026-00022
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 21, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K213513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE REPORTED EVENT IS NOT IN COMMERCIAL DISTRIBUTION UNDER A PREMARKET NOTIFICATION REGISTERED WITH FDA, AS THE DEVICE IN THE RECEIVED COMPLAINT IS DISTRIBUTED IN JAPAN ONLY. FOR THIS REASON, A US UDI FOR THIS CATALOG NUMBER IS NOT APPLICABLE. THIS REPORT IS BEING SUBMITITED AS THERE IS AN EQUIVALENT DEVICE MARKETED IN THE US. THERE WERE THREE DEVICES IMPACTED BY THIS COMPLAINT AND A SEPARATE MDR IS BEING SUBMITTED FOR EACH DEVICE. THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 24 APRIL 2026, THE MANUFACTURER'S MAH IN JAPAN REPORTED THAT DURING INCOMING INSPECTION, FOREIGN MATTER WAS IDENTIFIED WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THIS DEFICIENCY WAS FOUND PRIOR TO USE. THE DEVICE HAD NOT YET ENTERED INTO THE DISTRIBUTION STAGE TO THE END USER (I.E. BEING PUT INTO SERVICE), SO THERE WAS NO HEALTH IMPACT TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214514 VENTED VIAL ADAPTER 20MM Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD. K961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown