BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD COLLECTION TUBE

    MDR report key: 10934350 · Received December 2, 2020

    Report

    Report Number
    10934350
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 7, 2020
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS RN WAS CALLED INTO PATIENT'S ROOM BY CNA. CNA WAS DRAWING AN ANTI-XA. CNA STATED THAT WHEN SHE WENT TO PULL THE LIGHT BLUE TUBE OFF OF THE TRANSFER DEVICE, THE TOP CAME OFF FROM THE CLEAR PORTION. PATIENT'S BLOOD WAS DRAWN AGAIN AND SENT TO LAB IN NEW TUBE. LOT NUMBER ON BLUE TUBE: 0072486, EXPIRATION 2020-12-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399114 BLOOD COLLECTION TUBE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA 0072486

    Patients

    Seq Age Sex Outcome Treatment
    1