BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 65340 · Received January 24, 1997

    Report

    Report Number
    2026191-1996-00070
    Event Type
    Malfunction
    Date Received
    January 24, 1997
    Date of Event
    December 13, 1996
    Report Date
    December 23, 1996
    Manufacturer
    BARD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IAB INSERTED 12/11/96 FOR CARDIOGENIC SHOCK, STATUS POST MVF. LATER THAT DAY, IAB CATHETER ALARMED AND APPROX. 30 MINUTES LATER THE NURSING STAFF NOTICED BLOOD IN THE TUBING. IAB WAS REMOVED AND NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD IAB CATHETER DSP BARD 0600606 507840

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR