BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONGUARD-2 CSTD LUER-LOCK ADAPTOR

    MDR report key: 23980573 · Received January 6, 2026

    Report

    Report Number
    MW5181869
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    November 23, 2025
    Report Date
    December 30, 2025
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSING TECHNICIAN FOUND IV TUBING NOT CONNECTED TO PATIENT WHILE CHEMOTHERAPY INFUSING; WAS FOUND INFUSING/LEAKING INTO THE PATIENT'S BED. ONGUARD-2 CSTD LEUR-LOCK ADAPTER HAD BECOME DISCONNECTED/UNSECURED FROM THE INJECTION CAP ON PATIENT'S INDWELLING IV LINE. CHEMO SPILL PRECAUTIONS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47848 ONGUARD-2 CSTD LUER-LOCK ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. UBM601

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention FLUOROURACIL.