BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL PURPOSE PROBE COVER

    MDR report key: 3231325 · Received July 11, 2013

    Report

    Report Number
    MW5030902
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ECOLAB MICROTEK MEDICAL
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EPI AORTIC ULTRASOUND COMPLETED AS USUAL DURING THIS PROCEDURE. WHEN REMOVING THE PROBE FROM THE CHEST, A LEAK WAS NOTED COMING OUT OF THE PROBE COVER. THE FLUID USED DURING THE ULTRASOUND (INSIDE THE PROBE COVER) THEN LEAKED ONTO THE HEART AND CHEST CAVITY. THE CHEST WAS IRRIGATED WITH ANTIBIOTIC IRRIGATION AND THE DRAPES THAT WERE CONTAMINATED WERE COVERED IMPERVIOUS STERILE DRAPES TO REESTABLISH THE STERILE FIELD IN THIS AREA. INSPECTION OF THE DRAPE AT THE END OF THE PROCEDURE BY THE PHYSICIAN REVEALED THE SEAMS OF THE PROBE COVER ON BOTH SIDES WERE LEAKING. THIS PRODUCT COMES IN THE OPEN HEART PACK WHICH IS PROVIDED BY AVID. THE PACKAGE INSERT WITH LOT NUMBERS WAS GIVEN TO OPERATING ROOM PURCHASING AGENT AS STANDARD PROCEDURE FOR DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321258 GENERAL PURPOSE PROBE COVER GENERAL PURPOSE PROBE COVER MED ECOLAB MICROTEK MEDICAL 6" X 48" NONLATEX AVID - 874384

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization