BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWABABLE VIAL ADAPTER 13MM

    MDR report key: 25217723 · Received May 19, 2026

    Report

    Report Number
    3000223297-2026-00018
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 19, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    UDI-DI
    07290108240498
    PMA / PMN Number
    K072511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION AND WILL TAKE INTO ACCOUNT LOT L507. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER, DOMPE FARMACEUTICI SPA, CONTACTED THE DEVICE MANUFACTURER ON 22APR2026 TO REPORT DURING PACKAGING OF THE SWABABLE VIAL ADAPTER (SVA) WITH THE CUSTOMER'S DRUG PRODUCT, FOREIGN PARTICLES WERE DETECTED WITHIN THE PRIMARY PACKAGING OF THE DEVICES AND ALSO WITHIN THE SEALING AREA OF THE PRIMARY PACKAGING. THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. 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), THERE WAS NO HEALTH IMPACT TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48930 SWABABLE VIAL ADAPTER 13MM Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD. L507 07290108240498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown