BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10% NEUTRAL BUFFERED FORMALIN CONTAINER

    MDR report key: 11884726 · Received May 26, 2021

    Report

    Report Number
    11884726
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 20, 2021
    Report Date
    May 24, 2021
    Manufacturer
    SLMP LLC (STATLAB MEDICAL PRODUCTS)
    Product Code
    NNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPECIMEN TRANSPORT CONTAINER DOES NOT CLOSE PROPERLY AND ALLOWS LEAKAGE FROM CONTAINER. THIS OCCURRED ON FOUR SEPARATE OCCASIONS OVER TWO WEEKS. THESE CONTAINERS ARE MANUFACTURED TO CONTAIN FORMALIN. THE CONTAINER APPEARS TO BE CLOSED, BUT UNFORTUNATELY LEAKED FORMALIN DURING TRANSPORTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785535 10% NEUTRAL BUFFERED FORMALIN CONTAINER CONTAINER, SPECIMEN, NON-STERILE NNI SLMP LLC (STATLAB MEDICAL PRODUCTS) 119011

    Patients

    Seq Age Sex Outcome Treatment
    1