BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 961453 · Received November 16, 2007

    Report

    Report Number
    961453
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    September 19, 2007
    Report Date
    September 21, 2007
    Manufacturer
    THERMO FISHER SCIENTIFIC INC
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    4 OZ. SPECIMEN CONTAINERS ARE LEAKING EVEN AFTER TIGHTLY SECURING LIDS. THE SPECIMEN CONTAINERS ARE NON-STERILE AND ARE SUPPLIED WITH THE LIDS. CONTINUES TO BE A HAZARDOUS CONDITION DUE TO LEAKS. APPEARS THAT THE LIDS ARE NOT FITTING PROPERLY ON CONTAINERS. THE CONTAINERS MAY CONTAIN SURGERY SPECIMENS THAT WILL SAFELY FIT INTO THEM. FORMALIN IS USUALLY ADDED INTO THE CONTAINER WITH THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SPECIMEN CONTAINER LIO THERMO FISHER SCIENTIFIC INC 242210 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *