BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CENTRAL LINE

    MDR report key: 10069644 · Received May 18, 2020

    Report

    Report Number
    MW5094535
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 6, 2020
    Manufacturer
    ARROW INTERNATIONAL INC. / TELEFLEX, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CENTRAL LINE BROKEN GUIDEWIRE. THE GUIDEWIRE BROKE AS THE MD WAS WITHDRAWING THE CENTRAL LINE. THE DISTAL PORT WAS CLAMPED AND CAPPED. THE 2 OTHER PORTS DREW EASILY AND FLUSHED WITHOUT DIFFICULTY. CENTRAL LINE RETRIEVED AND APPEARS TO BE WHOLE. CENTRAL LINE INSERTION IN A CODE BLUE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531967 ARROW CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ARROW INTERNATIONAL INC. / TELEFLEX, INC. CDC-45703-P1A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention