BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA TECH

    MDR report key: 540178 · Received August 19, 2004

    Report

    Report Number
    2523676-2004-00061
    Event Type
    Injury
    Date Received
    August 19, 2004
    Date of Event
    July 9, 2004
    Report Date
    August 16, 2004
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, A VENA TECH LGM FILTER WAS INADVERTENTLY SNARED BY A GUIDEWIRE DURING A BLIND CENTRAL VENOUS CATHETER PLACEMENT. TWO DAYS LATER THE PT WAS SENT TO THE RADIOLOGY DEPARTMENT WHERE AN ATTEMPT TO FREE THE GUIDEWIRE WAS MADE. THE ATTEMPT WAS NOT SUCCESSFUL. NO INJURY TO THE PT WAS REPORTED. THE GUIDEWIRE REMAINS ENGAGED IN THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH VENA CAVA FILTER DTK B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention