BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDIGUARD IAB CATHETER

    MDR report key: 164706 · Received April 22, 1998

    Report

    Report Number
    1222008-1998-00108
    Event Type
    Malfunction
    Date Received
    April 22, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 2, 1998
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 6/12/98. UF#: 260038-19998-3. INTERNAL # 061998040011.

    Description of Event or Problem · 1

    AFTER 24 HRS OF IAB THERAPY, ALARMS SOUNDED AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED. NO FURTHER COMPLICATIONS OR PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDIGUARD IAB CATHETER Implant INTRA AORTIC BALLOON DSP BARD VASCULAR SYSTEM NA 13CH0072

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR