BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUETTE TUBE

    MDR report key: 19427871 · Received May 29, 2024

    Report

    Report Number
    MW5155558
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 22, 2024
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON OPENING A PACKAGE OF VACUETTE 8ML CAT SERUM SEP CLOT ACTIVATOR TUBES (BRAND GREINER BIO-ONE), ONE TUBE WAS FOUND WITH A CAP THAT HAD AN UNKNOWN SUBSTANCE THAT LOOKS LIKE DRIED BLOOD. OUTER PLASTIC PACKAGING HAS SOME SMALL RIPS. REFERENCE 455071P LOT B2308353 WXP 2025-01-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328732 VACUETTE TUBE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE NORTH AMERICA, INC. B2308353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention