BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 ML MEDLINE 10% NEUTRAL BUFFERED FORMALIN

    MDR report key: 22737011 · Received August 7, 2025

    Report

    Report Number
    22737011
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 17, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FMH
    UDI-DI
    10193489085594
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    90 ML MEDLINE 10% NEUTRAL BUFFERED FORMALIN CONTAINER LEAKING. CAPS PROPERLY SECURED AND THEN LEAKING ON ARRIVAL TO PATHOLOGY. HAS HAPPENED MULTIPLE TIMES IN BOTH OUR OR AND ENDOSCOPY SERVICES AND AT SISTER HOSPITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006308 90 ML MEDLINE 10% NEUTRAL BUFFERED FORMALIN CONTAINER, SPECIMEN, STERILE FMH MEDLINE INDUSTRIES, LP - NORTHFIELD MCHEMPF90N 219540 10193489085594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown