BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD 2 CSTD BAG ADAPTOR SP WITH ULTRASITE

    MDR report key: 22628375 · Received July 28, 2025

    Report

    Report Number
    MW5173393
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 24, 2025
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ADMINISTRATION FAM-TRASTUZUMAB DERUXTECAN-NXKI (ENHERTU) 390 MG IN DEXTROSE 5% 100 ML. WHILE EXTENDING THE TUBING TO PLACE INTO THE PUMP, I NOTICED DRIPS APPEARING ON THE FLOOR. WHERE THE SOFT FLEXIBLE TUBING MEETS THE SAFETY DEVICE/ CLIP THAT GOES INTO THE PUMP WAS DRIPPING. TUBING IS PRIMED WITH DEXTROSE AND NO CONCERN FOR A CHEMO SPILL. AREA WAS PROPERLY CLEANED UP AND PHARMACY WAS NOTIFIED. THE ENHERTU WAS PLACED BACK INTO THE CHEMO BAG AND DISPOSED OF IN THE CHEMO BIN AND A NEW TREATMENT WAS MIXED BY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107354 ONGUARD 2 CSTD BAG ADAPTOR SP WITH ULTRASITE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD 412146 UBB 535

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female FAM-TRASTUZUMAB DERUXTECAN-NXKI (ENHERTU) .