BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIFFUSICS ANGIOCATH

    MDR report key: 17119258 · Received June 12, 2023

    Report

    Report Number
    MW5118345
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    June 8, 2023
    Report Date
    June 8, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WAS PLACING A DIFFUSICS 24G ON A PATIENT WHEN SHE THREADED THE CATHETER AND PULLED THE NEEDLE BACK, THE SAFETY FEATURE DID NOT ENGAGE AND POPPED RIGHT OFF THE TOP WITH THE WHOLE NEEDLE EXPOSED. NO EMPLOYEE STICK, NO HARM TO PATIENT. LOT# 3010847, EXP 12/31/2025. REF# 383590.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308630 DIFFUSICS ANGIOCATH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383590 3010847

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown