BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENAPORT, MP, 90

    MDR report key: 409068 · Received July 31, 2002

    Report

    Report Number
    2951009-2002-00010
    Event Type
    Malfunction
    Date Received
    July 31, 2002
    Date of Event
    June 25, 2002
    Report Date
    July 29, 2002
    Manufacturer
    CARDIMA, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN TOOK OUT A VENAPORT MULTI 90 OUT OF THE PACKAGE AND SOAKED IT IN THE PHYSIOLOGICAL SALINE SOLUTION. THEN, WHILE WIPING THE SURFACE OF THE VENAPORT WITH GAUZE, THE TIP OF THE VENAPORT DETACHED FROM THE MAIN SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENAPORT, MP, 90 VENAPORT DQY CARDIMA, INC. 08-001015 P1503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN