BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIMEN CONTAINER

    MDR report key: 9659204 · Received February 3, 2020

    Report

    Report Number
    9659204
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    November 22, 2019
    Report Date
    November 29, 2019
    Manufacturer
    THERMO FISHER SCIENTIFIC (MONTERREY), S. DE R.L. DE C.V.
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NUMEROUS 10% NEUTRAL BUFFERED FORMALIN SPECIMEN CONTAINERS HAVE BEEN FOUND TO HAVE LEAKED IN TRANSPORT OF CRITICAL BIOPSY SPECIMENS. WE HAVE ALSO NOTICED NUMEROUS LEAKING CONTAINERS THAT HAVE NEVER BEEN OPENED OR RESECURED. MANY ARE STILL IN THE ORIGINAL SHIPPING BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122985 SPECIMEN CONTAINER CONTAINER, SPECIMEN, STERILE FMH THERMO FISHER SCIENTIFIC (MONTERREY), S. DE R.L. DE C.V. 497700

    Patients

    Seq Age Sex Outcome Treatment
    1