BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD2 SYRINGE ADAPTOR LOCK II

    MDR report key: 24952598 · Received April 22, 2026

    Report

    Report Number
    24952598
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 9, 2026
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVING IVP [IV PUSH] CINVANTI WHEN NURSE NOTICED HAD SLOW LEAK AT CONNECTION BETWEEN IV LINE AND ONGUARD 2 CSTD SYRINGE ADAPTOR LOCK II. LINE AND CONNECTOR EXCHANGED FOR NEW LINE AND CONNECTOR. PRODUCT ONGUARD 2 CSTD SYRINGE ADAPTOR LOCK II LOT # UBY589.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271324 ONGUARD2 SYRINGE ADAPTOR LOCK II CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD UBY589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other