BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 2923210 · Received January 18, 2013

    Report

    Report Number
    1226348-2013-11193
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    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

    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 WHEN VISUALLY INSPECTED IT WAS FOUND THAT THE TUBING AT THE NEEDLESS PORT HAS COME AWAY FROM THE NEEDLESS PORT. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED AT 100% TESTED FOR LEAKS AND BLOCKAGES AT IN PROCESS INSPECTION. AT INCOMING INSPECTION 23 PARTS WERE PULL TESTED, VALUES ARE ABOVE THE SPECIFIED LIMITS. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK PRIOR TO DISTRIBUTION. A REVIEW OF THE STERILIZATION CERTIFICATE CONFORMED TO SPECIFICATIONS WHEN RELEASED STOCK. ALTHOUGH IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE, IT MIGHT BE POSSIBLE THAT THE TUBING WAS PULLED CAUSING THE DISCONNECTION AS IT WAS NOTED IN THE EVENT DESCRIPTION THAT THE MOTHER OF THE PATIENT MANIPULATED THE DEVICE. THIS HOWEVER COULD NOT BE CONFIRMED. IN ADDITION, THE CAUSE OF THE FEVER COULD NOT BE DETERMINED AS THE DEVICE CONFORMED TO ALL STERILIZATION REQUIREMENTS PRIOR TO DISTRIBUTION. 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

    AFFILIATE REPORTED THAT: "ONE OF THE PATIENTS HAD A VENTRICULITIS THAT BECAME WORSE AFTER THE AFFILIATE REPORTED THAT ONE OF THE PATIENTS HAD VENTRICULITIS THAT BECAME WORSE AFTER THE LEAKAGE. THE PHYSICIAN SAYS THAT THERE WAS A LEAKAGE IN THE Y LUER LOCK CONNECTION WHEN THE SYSTEM IS CLAMPED. AFTER CHANGING THE SYSTEM (THEY KEPT THE VENTRICULAR CATHETER), THE CHILD GOT BETTER. USER IS ASSOCIATING THE EVENT WITH THE LOT AS A SECOND EVENT OCCURRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27830 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CNFB85

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention