BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW CONTROL VALVE, CONT. REGULAR, MEDIUM PRESSURE

    MDR report key: 204647 · Received December 31, 1998

    Report

    Report Number
    2021898-1998-00172
    Event Type
    Malfunction
    Date Received
    December 31, 1998
    Date of Event
    December 2, 1998
    Report Date
    December 2, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE SCHEDULED REQUIRING MEDIUM PRESSURE VALVE. PREOPERATIVE INSPECTION REVEALED THREE DOTS ON THE VALVES THAT WERE LABELED MEDIUM PRESSURE (ALL SIX OF THIS LOT THAT THE HOSP HAD IN STOCK). THIS INDICATED THAT THE VALVES WERE HIGH PRESSURE NOT MEDIUM PRESSURE AS LABELED. (SEE ALSO MFR REPORT #2021898-1998-00170, -00171, -00173, -00174, -00175.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW CONTROL VALVE, CONT. REGULAR, MEDIUM PRESSURE Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA R1091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA