BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVER PRESSURE SAFETY VALV

    MDR report key: 55056 · Received October 11, 1996

    Report

    Report Number
    1222008-1996-00052
    Event Type
    Malfunction
    Date Received
    October 11, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 11, 1996
    Manufacturer
    BARD VASCULAR INDUSTRIAL PK
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAKAGE FROM THE PRESSURE RELIEF VALVE DURING THE OPERATIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER PRESSURE SAFETY VALV OPS KRI BARD VASCULAR INDUSTRIAL PK NA 43HFV108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN