BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD®2 CSTD SYRINGE ADAPTOR

    MDR report key: 22686335 · Received August 1, 2025

    Report

    Report Number
    22686335
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 15, 2025
    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

    THIS NURSE NOTICED LIQUID UNDER THE PUMP THAT WAS RUNNING IN [REDACTED]. UPON ASSESSMENT IT WAS DETERMINED THE CISPLATIN HAD BEEN SLOWLY LEAKING THROUGH THE CHEMO ADAPTOR SITE. THE AREA WAS ABLE TO BE CLEANED UP WITH STRICT CHEMO PRECAUTIONS AND DID NOT REQUIRE A SPILL ACTIVATION. THERE WAS NO IMMEDIATE RISK TO THE PATIENT OR EMPLOYEES BUT THERE COULD HAVE BEEN EXPOSURE DUE TO THE CISPLATIN BEING AEROSOL-ABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178828 ONGUARD®2 CSTD SYRINGE ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD 412163 UBN672

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female