BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 23003752 · Received September 9, 2025

    Report

    Report Number
    23003752
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 26, 2025
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DELTAVEN 20 CATHETER PLACED WITH EXCELLENT BLOOD RETURN, HOWEVER BLOOD LEAKING AT NEEDLE EJECTION PORT. IV REMOVED, PLACED IN BIOHAZARD BAG FOR FURTHER IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495789 DELTAVEN FAST FLASH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 3831473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male