BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFILLED FORMALIN SPECIMEN CONTAINER 180ML

    MDR report key: 21850299 · Received April 16, 2025

    Report

    Report Number
    MW5169125
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 11, 2025
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IFP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDINAL HEALTH 180ML FORMALIN CONTAINERS LEAKING INTO SPECIMEN BAGS. SPECIMEN CONTAINERS ARE SECURED TIGHTLY. LEAKING SPECIMENS POSE A RISK TO PATIENT SAFETY (LOSS OF SPECIMEN OR DEGRADATION OF SPECIMEN) AND A SAFETY RISK TO LABORATORY AND TRANSPORT PERSONNEL. NO SPECIMEN LOSS HAS BEEN REPORTED. THIS FACILITY HAS NOTED THIS CONCERN WITH LOT #S 147858 EXP 10/2028, 221050 EXP 2/29/2028, AND 217915 EXP 1/31/2028. REFERENCE REPORTS: MW5169124, MW5169126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133357 PREFILLED FORMALIN SPECIMEN CONTAINER 180ML FORMALIN, NEUTRAL BUFFERED IFP CARDINAL HEALTH 221050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other