BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 25277631 · Received May 26, 2026

    Report

    Report Number
    25277631
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 28, 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

    20 G IV LEAKING AFTER INSERTION. IV WAS PLACED AND BLOOD WAS LEAKING FROM THE BOTTOM HUB OF BUTTERFLY AFTER PLACEMENT. LOT #11T45107 REF # 3836773. MANUFACTURER DELTAVEN DELTA MED FASTFLASH SAFETY IV CATHETER OF PUR WITH CLOSED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101980 DELTAVEN FAST FLASH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 3836773 11T45107

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other