BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD OPS VALVE

    MDR report key: 230080 · Received June 23, 1999

    Report

    Report Number
    1222008-1999-00021
    Event Type
    Injury
    Date Received
    June 23, 1999
    Report Date
    June 8, 1999
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    MNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OPS VALVE FAILED TO 'RELIEVE' DURING THE CASE CAUSING A SIGNIFICANT AMOUNT OF AIR TO BE INTRODUCED INTO THE PT'S HEART. AS A RESULT, THE PT WAS ON BYPASS AN ADDITIONAL 20MINS. TO DE-AIR THE HEART. THE PT'S AORTA WAS CROSS-CLAMPED AT THE TIME. NO PT INJURY OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD OPS VALVE OVERPRESSURE SAFETY VALV MNJ BARD VASCULAR SYSTEM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN