BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 493471 · Received October 31, 2003

    Report

    Report Number
    2925153-2003-00007
    Event Type
    Other
    Date Received
    October 31, 2003
    Date of Event
    June 6, 2003
    Report Date
    July 1, 2003
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER APPEARED TO HAVE A LEAK. DURING REMOVAL, CATHETER BROKE, TWICE. X-RAY CONFIRMED THAT THE DISTAL SEGMENT WAS RETAINED IN THE PT'S VENOUS SYSTEM. REMOVED VIA A FEMORAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC CATHETER DQO HDC CORP. 380-75 OR 400-166 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN