BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTS INLIN VLV W/UNIT BAC CAT

    MDR report key: 3040360 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-14970
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    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

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED AN OCCLUSION IN THE DEVICE AND FOR THE RETURNED VALVE TO FAIL THE PRESSURE TEST, WHICH APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. 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 THE PATIENT RECEIVED A VALVE, AND IT WAS NOTED THAT IT IS LIKELY THE DEVICE WAS NOT SUTURED. AT ONE POINT THE DEVICE WAS REPROGRAMMED, HOWEVER, AFTER THREE WEEKS, FLUID COLLECTION ABOVE THE VALVE WAS DETECTED. THE DEVICE WAS ONCE AGAIN PROGRAMMED. DUE TO AN OBSTRUCTION OF THE CATHETER IN THE ABDOMEN THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142939 CERTS INLIN VLV W/UNIT BAC CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMDDJT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention