BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLIAM HARVEY H130 OPSV

    MDR report key: 144562 · Received January 16, 1998

    Report

    Report Number
    1222008-1998-00010
    Event Type
    Injury
    Date Received
    January 16, 1998
    Date of Event
    December 10, 1997
    Report Date
    December 24, 1997
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    MNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILED PERFORMANCE PRESSURE TESTING DUE TO MANUFACTURING PROCESS. A FAILURE INVESTIGATION AND CORRECTIVE PREVENTIVE ACTION IMPLEMENTED: FDA WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLIAM HARVEY H130 OPSV OVERPRESSURE SAFETY VALV MNJ BARD VASCULAR SYSTEM NA 43H9V106

    Patients

    Seq Age Sex Outcome Treatment
    1