BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITOSWAB VTM

    MDR report key: 11684982 · Received April 16, 2021

    Report

    Report Number
    MW5100834
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 14, 2021
    Manufacturer
    CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD.
    Product Code
    QMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CITOSWAB VTM CONTAINER BROKE. THE LID SPLIT INTO TWO PIECES THE THREADED PART CAME AWAY FROM THE TOP AND THE VTM COULD HAVE LEAKED OUT. THIS THANKFULLY BROKE WHILE OPENING THE CONTAINER IN THE LAB SO THAT SAMPLE WAS ABLE TO BE USED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580071 CITOSWAB VTM TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE QMC CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD. VTM 092044

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR