BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 5543957 · Received April 4, 2016

    Report

    Report Number
    1226348-2016-10256
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    March 11, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EDS III WAS VISUALLY INSPECTED, IT SEEMS THAT BIOLOGICAL DEBRIS HAS COME INTO CONTACT WITH THE FILTER IN THE BURETTE. THE EDS III WAS SET UP AS PER IFU. THE DRIP CHAMBER STOP COCK WAS TURNED TO THE OFF POSITION. 20ML OF PURIFIED WATER WAS FLOWED INTO THE DRIP CHAMBER. THE SYSTEM STOPCOCK WAS THEN CLOSED. THE DRIP CHAMBER STOPCOCK WAS OPENED; THE PURIFIED WATER FLOWED NORMALLY AND EMPTIED INTO THE COLLECTION BAG. THIS PROCESS WAS REPEATED WITH THE SAME RESULT, THE EDS III FUNCTIONS. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3844, WITH LOT CLHB5W, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2015. NO ROOT CAUSE COULD BE DETERMINED AS THE EDS III FUNCTIONED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AS TO THE OPINION OF THE DOCTOR (NEUROSURGEON), THE CONTENT OF THE DRIP CHAMBER DID NOT EMPTY OUT IN A NORMAL WAY (NOT SWIFT ENOUGH). TO RESOLVE THE PROBLEM, ANOTHER 821731 SYSTEM WAS COUPLED TO THE CATHETER (WITH PRODUCT CODE 82-1707 AND LOT NUMBER 658638). INDICATION WAS DRAINAGE OF LUMBAR CSF (USE IN INTENSIVE CARE). THE GOAL WAS TO DRAIN 10CC/H. IF THIS GOAL COULDN'T BE REACHED, THE SYSTEM NEEDED TO BE ADAPTED. MAR. 15, 2016 PER AFFILIATE, IN ANSWER TO THE QUESTION IF THE SECOND EDS DRAINED PROPERLY: "YES INDEED, THE NEW ONE DRAINED QUICK ENOUGH. SO NO FURTHER ACTIONS NEEDED TO BE TAKEN." AND THE PREVIOUS EVENT: "ALSO HAPPENED DURING THE PROCEDURE (SO INTRA-OPERATIVELY), BUT DIDN'T CAUSE A DELAY OVER 30 MINUTES. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE MENTIONED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200868 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTNBRY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention