BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD 2 CSTD SYRINGE ADAPTOR A CHEMFORT CSTD PRODUCT

    MDR report key: 16701660 · Received April 6, 2023

    Report

    Report Number
    MW5116455
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 4, 2023
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WAS PREPARING TO HANG CHEMOTHERAPY AND THE ONGUARD (R) 2 CSTD SYRINGE ADAPTOR ON THE END OF THE LINE FAILED, BREAKING OFF AND EXPOSING THE NEEDLE. THIS WAS A DESENSITIZATION, SO THE LINE WAS PRIMED WITH DRUG CREATING A POTENTIAL EXPOSURE RISK. NO CHEMO WAS NOTED TO HAVE SPILLED OR DRIPPED. THE PRODUCT WAS DISCARDED AS A SHARP WHICH CONTAINED CHEMOTHERAPY. PATIENT NOT IMPACTED. STAFF NOT EXPOSED. DISTRIB BY B. BRAUN MED. UNKNOWN-PACKAGING WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440704 ONGUARD 2 CSTD SYRINGE ADAPTOR A CHEMFORT CSTD PRODUCT CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD. 412163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown