BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM II

    MDR report key: 1622283 · Received March 2, 2010

    Report

    Report Number
    1226348-2010-00056
    Event Type
    Injury
    Date Received
    March 2, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. PLEASE NOTE THAT THIS COMPLAINT WAS INITIALLY REPORTED AS AN EDS3 SYSTEM P/N 82-1730, HOWEVER, A SECTION OF AN EDSII P/N 82-1720 OR 82-1721 (IT CAN'T BE DETERMINED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED) WAS RETURNED FOR EVAL. FOR THE PURPOSES OF REPORTING, THIS COMPLAINT WILL BE HANDLED AS P/N 82-1720, LOT # UNK. (EDSII - COMPLETE WITH VENTRICULAR CATHETER). A SECTION OF EDSII SYSTEM P/N 82-1720 WAS RETURNED FOR EVAL. THIS INCLUDES THE "PATIENT ICP MONITORING LINE" ATTACHED TO THE STOPCOCK, THE TUBING BETWEEN THE "CSF SAMPLING OR FLUID INJECTION SITE" AND THE STOPCOCK. ATTACHED TO THE "CSF SAMPLING OR FLUID INJECTION SITE" IS ALSO A SMALL PORTION OF TUBING OF APPROXIMATELY 2 1/8" IN LENGTH. AS RECEIVED, THE TUBING BETWEEN THE "STOPCOCK" AND THE "CSF SAMPLING OR FLUID SITE" IS DETACHED FROM THE STOPCOCK. VISUAL EXAMINATION UNDER APPROPRIATE MAGNIFICATION VERIFIED THAT AT SOME POINT THE TUBE WAS PROPERLY GLUED TO THE STOPCOCK. EVIDENCE OF GLUE WAS OBSERVED AT THE AREA OF DETACHMENT. THE CAUSE(S) FOR THE DETACHMENT COULD NOT BE FULLY DETERMINED, HOWEVER, INAPPROPRIATE PULLING FORCES MAY HAVE CAUSED THE REPORTED DIFFICULTY, BUT IT COULD NOT BE CONFIRMED. NOTE THAT THESE TYPES OF PRODUCTS ARE 100% INSPECTED FOR LEAKAGE DURING THE MANUFACTURING PROCESS. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, THE LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED. 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

    REP REPORTED THAT TUBING BECAME BROKEN OR DISCONNECTED AFTER THE PORT LABELED CSF, WHERE IT ATTACHES TO THE STOP COCK. HOSPITAL REPORTED THAT THERE WAS A SMALL AMOUNT OF LEAKAGE WITH NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EXTERNAL DRAINAGE SYSTEM II SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention