BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 3132954 · Received May 29, 2013

    Report

    Report Number
    1226348-2013-17715
    Event Type
    Injury
    Date Received
    May 29, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE TWO PATIENT LINES TUBING AND ONE THREE WAY PATIENT LINE STOPCOCK WERE RETURNED FOR EVALUATION. AS RECEIVED, THE TUBING WAS DISLODGED FROM THE THREE WAY PATIENT LINE STOPCOCK. THE CAUSE(S) FOR THE DISLODGEMENT COULD NOT BE DETERMINED; HOWEVER, ADHESIVE TRACES WERE OBSERVED ON THE THREE WAY PATIENT LINE STOPCOCK AND THE TWO PATIENT LINES TUBING. NOTE THAT THESE PRODUCTS ARE 100% TESTED FOR LEAKAGE AND BLOCKAGE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED. CAPA - (B)(4) HAS BEEN OPENED TO ADDRESS THIS TYPE OF ISSUES. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE DRAIN WAS HOOKED UP AND THERE WAS A DISCONNECTION AT THE 3 WAY STOPCOCK AT THE PATIENT LINE. AS A RESULT, THE DRAIN WAS REPLACED. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234881 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention