BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 24616758 · Received March 17, 2026

    Report

    Report Number
    24616758
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 3, 2026
    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

    AFTER INSERTING THE IV AND RETRACTING THE NEEDLE, THE ONE-WAY VALVE WAS LEAKING WHEN FLUSHED. THE NURSE WAS UNABLE TO USE THE CATHETER AND REQUIRED ANOTHER IV TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684227 DELTAVEN FAST FLASH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 3845773 11T15109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other