BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH PICC/HDC CORPORATION

    MDR report key: 360419 · Received November 16, 2001

    Report

    Report Number
    MW1023380
    Event Type
    Malfunction
    Date Received
    November 16, 2001
    Date of Event
    November 7, 2001
    Report Date
    November 8, 2001
    Manufacturer
    HDC CORPORATION
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLACED PICC LINE IN PATIENT WITHOUT DIFFICULTY. PICC CATHETER DEVELOPED A TEAR IN THE CATHETER NEAR THE HUB. BREAK WAS NOT APPARENT DURING PREPLACEMENT FLUSHING. PICC LINE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51886 V-CATH PICC/HDC CORPORATION * DQO HDC CORPORATION REF.NO 360-55 1122

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other