BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML, 13X75 LAVENDER CAP-WHITE RING NON-RIDGED, USA

    MDR report key: 18978383 · Received March 25, 2024

    Report

    Report Number
    MW5153141
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 21, 2024
    Report Date
    March 21, 2024
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MALFUNCTION OF A GREINER BIO-ONE VACUETTE TUBE RESULTING IN A LOW VOLUME BLOOD SPLATTER WITHOUT HARM TO PATIENT AND WITHOUT EXPOSURE TO STAFF. TUBE SPECIFICATIONS: 2 ML, 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED, USA, K2E K2EDTA, 454428, LOT B2311376, EXPIRATION DATE 03-02-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047594 VACUETTE TUBE 2 ML, 13X75 LAVENDER CAP-WHITE RING NON-RIDGED, USA TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE NORTH AMERICA, INC. B2311376

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female