BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONGUARD2 CSTD BAG ADAPTOR SP WITH ULTRASITE

    MDR report key: 21620751 · Received March 17, 2025

    Report

    Report Number
    MW5167715
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    March 12, 2025
    Report Date
    March 12, 2025
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONGUARD2 CSTD BAG ADAPTOR SP WITH ULTRASITE, THE TUBING ADJACENT TO THE NEEDLE-FREE VALVE CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884710 ONGUARD2 CSTD BAG ADAPTOR SP WITH ULTRASITE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. UBB530

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown