BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALIN

    MDR report key: 22736846 · Received August 7, 2025

    Report

    Report Number
    22736846
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 22, 2025
    Manufacturer
    AZER SCIENTIFIC, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AZER SCIENTIFIC PFNBF - 480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALIN LEAKING UPON ARRIVAL TO PATHOLOGY. HAPPENED WITH SEVERAL BOTTLES NO MATTER HOW TIGHTLY YOU SECURE THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121598 480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALIN FORMALIN, NEUTRAL BUFFERED IFP AZER SCIENTIFIC, INC. PFNBF-480 40884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown