BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUCATH ACE INTRAVASCULAR CATHETER

    MDR report key: 20599036 · Received November 1, 2024

    Report

    Report Number
    MW5162098
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO PLACE AN 18G ACCUCATH IN PATIENT'S LAC, THE ACCUCATH GUIDEWIRE APPEARED TO FISHHOOK AND BECAME LODGED UNDER PATIENT'S SKIN. PA WAS CONTACTED. PA MADE SMALL SKIN NIK AND WIRE WAS REMOVED INTACT. DRESSING OF GAUZE AND TAPE APPLIED. PATIENT TOLERATED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461683 ACCUCATH ACE INTRAVASCULAR CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BARD REYNOSA S.A. DE C.V. AC1182252 REJR1631

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention