BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMALIN CONTAINER

    MDR report key: 17419638 · Received July 28, 2023

    Report

    Report Number
    17419638
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 5, 2023
    Manufacturer
    E K INDUSTRIES, INC.
    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

    6 FORMALIN JARS FOUND IN DRAWER WITH CRACKED LIDS ALL WITH LOT# 2215441 EXP [REDACTED DATE]. ADDITIONAL FORMALIN CONTAINER WAS FOUND TO HAVE LARGE CRACK IN LID. LOT# 2229926 EXP [REDACTED DATE]. MANUFACTURER RESPONSE FOR FORMALIN CONTAINER, (BRAND NOT PROVIDED) (PER SITE REPORTER) NOTIFIED THEM IN JANUARY, ESCALATED IT TO THEM OR CORRECTION. ALREADY CONVERTING TO A DIFFERENT BRAND DUE TO ONGOING ISSUES AND CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815088 FORMALIN CONTAINER FORMALIN, NEUTRAL BUFFERED IFP E K INDUSTRIES, INC. 24499-100X60ML 2215441, 2229926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown