BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 25277468 · Received May 26, 2026

    Report

    Report Number
    25277468
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 6, 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

    RN ASSISTED ANOTHER RN WITH PLACING NEW PIV [PERIPHERAL IV] ON PATIENT. WHEN PULLING BACK ON NEEDLE, THE NEEDLE DETACHED FROM CATHETER HUB LEAVING THE SHARP TIP EXPOSED. NO POKES TO EITHER RN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244835 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 79 YR Female Other