BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA MICROTIP AND FLUE PAK

    MDR report key: 32726 · Received May 6, 1996

    Report

    Report Number
    MW1009035
    Event Type
    Malfunction
    Date Received
    May 6, 1996
    Date of Event
    April 23, 1996
    Report Date
    May 2, 1996
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    LBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NURSING SPECIALIST WAS SETTING UP UNIT FOR A CRANIOTOMY PROCEDURE PRIMING THE HANDPIECE, IT WAS NOTED THAT THERE WAS NO IRRIGATION COMING FROM THE TIP. ANOTHER HANDPIECE WAS OBTAINED, FLASH STERILIZED AND INSTALLED. IRRIGATION WAS OK ON PRIMING. DEFECTIVE TIP TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA MICROTIP AND FLUE PAK IRRIGATION CATHETER AND TIP LBK VALLEYLAB, INC. CV 720-727-000 24229

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO