BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 13MM SWABABLE

    MDR report key: 23266103 · Received October 10, 2025

    Report

    Report Number
    3000223297-2025-00006
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    August 1, 2025
    Report Date
    June 4, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K072511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER, (B)(6), CONTACTED THE DEVICE MANUFACTURER ON (B)(6) 2025 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. FOREIGN PARTICLES WERE DETECTED IN MULTIPLE DEVICES FROM LOTS, K703, K704 AND K714 OF THE SWABABLE VIAL ADAPTERS (SVA). THE CUSTOMER CONFIRMED THAT THE AFFECTED DEVICES ARE SEGREGATED, NOT FOR USE. THIS DEFICIENCY WAS FOUND PRIOR TO USE. ON (B)(6) 2025, THE CUSTOMER INFORMED THE DEVICE MANUFACTURER THAT THE SAME ISSUE WAS IDENTIFIED WITH LOT: K715. 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
    304828 VIAL ADAPTER 13MM SWABABLE VIAL ADAPTER 13MM SWABABLE LHI WEST PHARMA. SERVICES IL, LTD. K703, K704, K714, K715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown