BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMERIEUX WORKSAFE

    MDR report key: 10966934 · Received December 8, 2020

    Report

    Report Number
    10966934
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    December 23, 2019
    Report Date
    November 27, 2020
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    OIB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I HAD TWO TUBES THAT WOULDN'T DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435755 BIOMERIEUX WORKSAFE BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING) OIB BIOMERIEUX, INC. 4053578

    Patients

    Seq Age Sex Outcome Treatment
    1