BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN

    MDR report key: 14083584 · Received April 12, 2022

    Report

    Report Number
    14083584
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    February 15, 2022
    Report Date
    April 5, 2022
    Manufacturer
    SLMP LLC (STATLAB MEDICAL PRODUCTS)
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO ADDITIONAL STATLAB 20 ML 10% NEUTRAL BUFFERED FORMALIN SPECIMEN TRANSPORT CONTAINERS HAVE CRACK IN THE LID. ONE HAD BONE MARROW SPECIMEN IN IT, THE OTHER WAS EMPTY AND IN HISTO STOCK AREA. LOT# 116290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278459 FORMALIN FORMALIN, NEUTRAL BUFFERED IFP SLMP LLC (STATLAB MEDICAL PRODUCTS) 116290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown