BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONGAURD2 SPIKE ADAPTER

    MDR report key: 23809987 · Received December 15, 2025

    Report

    Report Number
    MW5180539
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 9, 2025
    Manufacturer
    B. BRAUN MEDICAL INC./ SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    B BRAUN CLOSED SYSTEM TRANSFER DEVICE ONGAURD 2 - SPECIFICAL THE SPIKE SET PULLING LOOSE FROM IV BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743525 ONGAURD2 SPIKE ADAPTER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB B. BRAUN MEDICAL INC./ SIMPLIVIA HEALTHCARE LTD. 412165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention