BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-FILLED FORMALIN

    MDR report key: 20211219 · Received September 13, 2024

    Report

    Report Number
    20211219
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    November 3, 2023
    Report Date
    November 7, 2023
    Manufacturer
    AZER SCIENTIFIC, INC.
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAULTY PACKAGING FOR THE PRE-FILLED FORMALIN. WE RECEIVED THE REPLACEMENT ITEM FOR THE ONE THAT WAS DAMAGED ON MONDAY, BUT UNFORTUNATELY, THE REPLACEMENT IS ALSO DAMAGED. THE FEDEX DRIVER WHO DELIVERED THE ITEM WAS NOT AWARE THAT IT WAS LEAKING, AND AS A RESULT, THE PRODUCT SPILLED ALL OVER THE TRUCK. THIS CAUSED THE DRIVER TO EXPERIENCE WATERY EYES AND AN UNCOMFORTABLE IRRITATION IN HER NOSE. THE DRIVER DECIDED TO QUIT HER JOB ON THE SAME DAY, AS THE PACKAGING OF THE PRODUCT IS DEFECTIVE. WE KINDLY REQUEST YOU TO PASS ON THIS INFORMATION TO THE RELEVANT DEPARTMENT, SO THEY CAN TAKE NECESSARY ACTIONS TO CHANGE HOW PRODUCT NUMBER [PRODUCT # REDACTED] IS LABELED. WE APPRECIATE YOUR EFFORTS. HOWEVER, PLEASE DO NOT SEND US A REPLACEMENT FOR THIS PRODUCT. WE WILL PURCHASE IT FROM AN ALTERNATE SOURCE. MANUFACTURER RESPONSE FOR PRE-FILLED FORMALIN, PRE-FILLED FORMALIN (PER SITE REPORTER), NO RESPONSE AS OF YET

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263103 PRE-FILLED FORMALIN FORMALIN, NEUTRAL BUFFERED IFP AZER SCIENTIFIC, INC. PFNBF-1-25G 34957

    Patients

    Seq Age Sex Outcome Treatment
    1 122 YR Unknown