BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN SCIENTIFIC PREFILLED 10% NEUTRAL BUFFERED FORMALIN CONTAINERS

    MDR report key: 9676420 · Received February 6, 2020

    Report

    Report Number
    9676420
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    November 5, 2019
    Report Date
    November 11, 2019
    Manufacturer
    THERMO FISCHER SCIENTIFIC
    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

    SEVERAL 10% NEUTRAL BUFFERED FORMALIN SPECIMEN CONTAINERS HAVE BEEN FOUND TO HAVE LEAKED IN TRANSPORT OF CRITICAL BIOPSY SPECIMENS. WE HAVE ALSO NOTICED SEVERAL LEAKING CONTAINERS THAT HAVE NEVER BEEN OPENED AND RE-SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138983 RICHARD-ALLAN SCIENTIFIC PREFILLED 10% NEUTRAL BUFFERED FORMALIN CONTAINERS CONTAINER, SPECIMEN, STERILE FMH THERMO FISCHER SCIENTIFIC 496728

    Patients

    Seq Age Sex Outcome Treatment
    1