BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHY PACK

    MDR report key: 2183366 · Received July 21, 2011

    Report

    Report Number
    2183366
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    DEROYAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    WHILE THE RN WAS SETTING UP THE STERILE FIELD FOR A CARDIAC PROCEDURE, SHE OPENED A ANGIOGRAPHY PACK. SHE NOTED A DEAD WORM IN THE STERILE KIT. THE STERILE FIELD WAS TORN DOWN AND SET UP AGAIN. NO PATIENT CONTACT AS INCIDENT HAPPENED BEFORE PATIENT BROUGHT INTO ROOM.====================== MANUFACTURER RESPONSE FOR ANGIOGRAPHY PACK, ANGIOGRAPHY PACK (PER SITE REPORTER)======================CUSTOMER SERVICE REPRESENTATIVE, TERRI, NOTIFIED OF INCIDENT. (B) (4). THE MANUFACTURER WILL SEND A REPLACEMENT KIT. WORM WILL BE SENT TO MANUFACTURER FOR INVESTIGATION. PICTURE OF WORM AVAILABLE. WORM SENT TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGRAPHY PACK ANGIOGRAPHY PACK DQY DEROYAL * 25081847

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES