BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 24952724 · Received April 22, 2026

    Report

    Report Number
    24952724
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 8, 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

    WHEN PLACING A CATHETER, THE CAP DID NOT DIS-ATTACH FROM THE HUB DURING NEEDLE REMOVAL. THIS LEFT AN EXPOSED SHARP NEEDLE TIP. NEITHER THE PATIENT NOR THE RN WERE POKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011045 DELTAVEN FAST FLASH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 3825773 11T15251

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Other