BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 4101853 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11987
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 8, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EDS III WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE EDS III DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS UNKNOWN, PRODUCT CODE 82-1731. THE EDS III WAS VISUALLY INSPECTED, BIOLOGICAL DEBRIS WAS FOUND IN THE DRIP CHAMBER, AND THE COLLECTION BAG, AND THIS WAS REMOVED WITH A SYRINGE. BIOLOGICAL DEBRIS HAS COME INTO CONTACT WITH THE FILTER IN THE DRIP CHAMBER.THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION. THE DRIP CHAMBER WAS THEN FILLED UP TO THE 20ML MARK WITH PURIFIED WATER. THE SYSTEM STOPCOCK WAS THEN CLOSED. THE DRIP CHAMBER STOPCOCK WAS OPENED; THE PURIFIED WATER FLOWED, AND EMPTIED INTO THE COLLECTION BAG. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED, AS THE PURIFIED WATER FLOWED FROM THE DRIP CAMBER INTO THE COLLECTION BAG. DUE TO THE RESULT OF THE INVESTIGATION, NO CORRECTIVE ACTION NEEDED. TRENDS ARE BEING MONITORED WITH (B)(4). AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: DRAIN HAS BEEN DIFFICULT TO DRAIN FLUID FROM THE DRIP CHAMBER INTO THE COLLECTION BAG. AFTER SEVERAL ATTEMPTS TO DRAIN FLUID THE HEALTH PROFESSIONAL DECIDED TO CHANGE THE SYSTEM WITH A SECOND EDS 3 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582182 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention