BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD 2 CSTD SYRINGE ADAPTOR BRAUN

    MDR report key: 20256203 · Received September 19, 2024

    Report

    Report Number
    20256203
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 10, 2024
    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

    KYPROLIS WAS HUNG AND STARTED AT 1311. AT 1320, I RETURNED TO THE PATIENT TO TALK ABOUT A NS BOLUS TO BE GIVEN AFTER CHEMO. I NOTICED THAT THE SECONDARY TUBING HAD COME DISCONNECTED FROM THE ON-GUARD SYRINGE ADAPTOR. CHEMO WAS DRIPPING DIRECTLY ON THE FLOOR. THE SYRINGE ADAPTOR WAS STILL CONNECTED TO THE ON GUARD LUER LOCK ADAPTOR. THE DRUG WAS STOPPED IMMEDIATELY. PT WAS MOVED TO ANOTHER AREA AND THE SPILL WAS CLEANED PER PROTOCOL. APPROXIMATELY 20ML WAS ON THE FLOOR. THE DOSE WAS RE-MADE BY PHARMACY, AT A LESSER MG OF 70MG, AS THEY ESTIMATED THE PATIENT RECEIVED APPROXIMATELY 28MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591569 ONGUARD 2 CSTD SYRINGE ADAPTOR BRAUN CLOSED ANTINEOPLASTIC HAZARDOUS DRUG RECONSTITUTION TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD UBN609

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male