BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 20309387 · Received September 26, 2024

    Report

    Report Number
    20309387
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 10, 2024
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    I WAS PLACING AN INTRAVENOUS LINE (IV) FOR MY POSITRON EMISSION TOMOGRAPHY (PET) RUBIDIUM PATIENT AND WHEN I GOT BLOOD RETURN AND RETRACTED THE NEEDLE BACK, THE NEEDLE WAS STILL EXPOSED AND DID NOT LOCK WITH THE SAFETY FEATURE, LEAVING THE NEEDLE EXPOSED, ALMOST POKING MYSELF. HIGH SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234905 DELTAVEN FAST FLASH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 3811473 11T15311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown