BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD®2 CSTD 20MM VIAL ADAPTOR AND 13MM CONVERTOR

    MDR report key: 16494751 · Received March 7, 2023

    Report

    Report Number
    16494751
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    March 17, 2023
    Report Date
    March 1, 2023
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE ONGUARD ADAPTOR USED FOR CHEMOTHERAPY COMPOUNDING IS SUPPOSED TO BE A CLOSED SYSTEM TO KEEP THE COMPOUNDER SAFE FROM UNNECESSARY EXPOSURE TO HAZARDOUS DRUGS. THERE WAS A MALFUNCTION WITH ONE OF THE VIAL ADAPTORS IN THAT CHEMOTHERAPY CAN BE SEEN ON THE END OF IT, WHICH IS NOT SUPPOSED TO HAPPEN. THERE SHOULD NEVER BE CHEMOTHERAPY VISIBLE AS IT IS SUPPOSED TO BE A CLOSED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140521 ONGUARD®2 CSTD 20MM VIAL ADAPTOR AND 13MM CONVERTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD 412161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown