BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMINATED INFUSION CHANDELIER

    MDR report key: 1493404 · Received September 27, 2009

    Report

    Report Number
    1493404
    Event Type
    Malfunction
    Date Received
    September 27, 2009
    Date of Event
    July 31, 2009
    Report Date
    September 27, 2009
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CHANDELIER INFUSION CANNULA (SYNERGETICS, INC. 20 GAUGE) WAS USED AND INSERTED AT BEGINNING OF PRODCEDURE AS USUAL. WHEN THE LIGHT SOURCE WAS TURNED ON, THE TUBING APPEARED TO HAVE A TEAR OR HOLE IN IT. THE LIGHT WAS DISPERSED INCORRECTLY. A NEW LIGHTED INFUSION WAS PREPPED AND INSERTED WHEN THE FAULTLY ONE WAS REMOVED FROM THE PATIENT.THE PATIENT WAS NOT INJURED AND THE PROCEDURE WAS NOT COMPROMISED.

    Description of Event or Problem · 1

    A CHANDELIER INFUSION CANNULA (SYNERGETICS, INC. 20 GAUGE) WAS USED AND INSERTED AT BEGINNING OF PRODCEDURE AS USUAL. WHEN THE LIGHT SOURCE WAS TURNED ON, THE TUBING APPEARED TO HAVE A TEAR OR HOLE IN IT. THE LIGHT WAS DISPERSED INCORRECTLY. A NEW LIGHTED INFUSION WAS PREPPED AND INSERTED WHEN THE FAULTLY ONE WAS REMOVED FROM THE PATIENT.THE PATIENT WAS NOT INJURED AND THE PROCEDURE WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMINATED INFUSION CHANDELIER CANNULA, INFUSION, OPHTHALMOLOGY HMX SYNERGETICS, INC. * 9010514

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR