BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD 2 CSTD 20 MM VIAL ADAPTOR

    MDR report key: 25102571 · Received May 6, 2026

    Report

    Report Number
    MW5187803
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 1, 2026
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONGUARD 2 CSTD 20 MM VIAL ADAPTOR II CSTD PRODUCT, REF#412171 LOT UBX526 EXP 2028-06-30. THIS PRODUCT WAS ATTACHED TO AN ETOPOSIDE VIAL AND THEN THE MEDICATION WAS NOT ABLE TO BE DRAWN UP, POSSIBLY INTERNALLY THE PLASTIC IS FUSED SO NO FLOW GOES THROUGH THE PRODUCT. LED TO WASTING OF THE VIAL WITHOUT IT BEING ABLE TO BE USED. DEFECTIVE CSTD VIAL ADAPTOR THAT DOES NOT ALLOW FLUID TO FLOW THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515028 ONGUARD 2 CSTD 20 MM VIAL ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB SIMPLIVIA HEALTHCARE LTD 412171 UBX526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other