BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH, ACE 20GX2.25

    MDR report key: 19620757 · Received June 26, 2024

    Report

    Report Number
    3006260740-2024-03282
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 3, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    UDI-DI
    00801741137952
    PMA / PMN Number
    K162894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED, "ACCUCATH TRAINING GUIDEWIRE AND CATHETER THREADED BUT THE NURSE HIT THE SAFETY BUTTON THE BUTTON LOCKED AND WOULD NOT SAFETY THE NEEDLE LEAVING THE NEEDLE OUT AND EXPOSED. INSERTED IN RIGHT ARM, PATIENT WAS NOT AFFECTED BY THIS. ON THE SPINE/ORTHO FLOOR. OCCURRED AFTER PLACEMENT." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102159 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ C.R. BARD, INC. (BASD) -3006260740 N/A REHW1194 00801741137952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other