BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPN REDO

    MDR report key: 5842756 · Received August 3, 2016

    Report

    Report Number
    5842756
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    April 21, 2016
    Report Date
    June 16, 2016
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS GOING TO PLACE A BROVIAC AND THE WIRE IN THE CATHETER SET WAS BROKEN. REF (B)(4) LOT# 6061602. THE BROVIAC CATHETER SET INCLUDES A GUIDEWIRE. WHEN THE STERILE PACKAGE WAS OPENED THE GUIDEWIRE WAS BROKEN AND COULD NOT BE UTILIZED. ANOTHER BROVIAC GUIDEWIRE HAD TO BE OPENED IN ORDER FOR THE SURGEON TO PLACE THE BROVIAC. NO HARM CAME TO THE PATIENT. IT SEEMS TO BE A QUALITY CONTROL ISSUE WITH THE BROVIAC CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494719 TPN REDO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ COOK, INC. G07960 6061602

    Patients

    Seq Age Sex Outcome Treatment
    1