BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD

    MDR report key: 22962626 · Received September 4, 2025

    Report

    Report Number
    22962626
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 19, 2025
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CONTRAST WAS BEING RUN THROUGH THE PIV [PERIPHERAL INTRAVENOUS LINE] CONNECTOR TUBING (BD MAXGUARD KINK RESISTANT EXTENSION SET WITH NEEDLELESS Y-SITE), AND THE PRESSURE BLEW A HOLE IN THE TUBING, CAUSING CONTRAST TO LEAK OUT AND HIS IV TO BLEED THROUGH THE HOLE IN THE TUBING. TEGADERM AND OLD TUBING REMOVED; REPLACED WITH NEW TUBING AND TEGADERM; PIV REMAINED PATENT. TUBING: BD MAXGUARD KINK RESISTANT EXTENSION SET WITH NEEDLELESS Y-SITE: REF: MX9060, LOT: 24099252, EXP: 2027-09-06,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292689 MAXGUARD SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL MX9060 24099252

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male