BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTASIS VALVE/SHEATH ASSEMBLY

    MDR report key: 49490 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00097
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Report Date
    September 5, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS MORE LEAKING THAN USUAL FROM THE CLEAR HEMOSTASIS VALVE. THE HEMOSTASIS VALVE WAS NOT TAKEN OFF THE INTRODUCER. THE HEMOSTASIS VALVE AND INTRODUCER WERE NOT RETURNED TO THE CO. FOR EVALUATION. THE ITEMS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTASIS VALVE/SHEATH ASSEMBLY HEMOSTASIS VALVE/SHEATH ASSEMBLY DSP DATASCOPE CORPORATION 0684540015/0684-54-0008-03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN