BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN

    MDR report key: 24799676 · Received April 7, 2026

    Report

    Report Number
    24799676
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 26, 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 THE PERIPHERAL IV WAS INSERTED IN THE PATIENT'S VEIN, BLOOD LEAKED BACK FROM THE PORT. SITE WAS CLEANED AND BLEEDING DID NOT CONTINUE AND IV LINE WAS ABLE TO BE USED. NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860073 DELTAVEN CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ DELTA MED SPA 11T45107

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other