BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENAPORT,MP,90

    MDR report key: 368630 · Received December 18, 2001

    Report

    Report Number
    2951009-2001-00007
    Event Type
    Malfunction
    Date Received
    December 18, 2001
    Date of Event
    September 11, 2001
    Report Date
    December 17, 2001
    Manufacturer
    CARDIMA, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE PHYSICIAN WAS PULLING VENAPORT OUT OF PT, THE DISTAL END OF THE VENAPORT FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57103 VENAPORT,MP,90 GUIDE CATHETER DQY CARDIMA, INC. NA P1047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other