BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 5453985 · Received February 23, 2016

    Report

    Report Number
    1226348-2016-10144
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    October 20, 2015
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE 150MM OF CATHETER WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS COULD BE SEEN INSIDE THE CATHETER. THE 150MM OF CATHETER WAS IRRIGATED WITH PURIFIED WATER; SOME BIOLOGICAL DEBRIS WAS FLUSHED OUT. A RESEARCH FOR RELATED COMPLAINTS WAS DONE FOR PRODUCT CODE 82-1730 FOR THE LAST 3 YEARS, NO OTHER ISSUE WAS FOUND. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE PRODUCT CODE 82-1730 WITH LOT CTHBFM, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 25TH JUNE 2015. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE PRODUCT CODE 82-1730 WITH LOT CTFCZZ, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 1ST JUNE 2015. 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-1730, WITH LOT CTHBFM, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 25TH JUNE 2015. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AN EDSIII WAS PLACED FOR RECURRING HYDROCEPHALY. CRYSTALS WERE DETECTED IN THE SYSTEM BY THE NURSE. THE DOCTOR AHS DECIDED TO REMOVE THE SYSTEM ON (B)(6) 2015. 3CM WHITE CRYSTALS WERE FOUND IN THE CATHETER REMOVED. CLINICAL CONSEQUENCE : WORSENING OF CLINICAL SIGNS. ON (B)(6), CHANGE OF THE SYSTEM WITH A NEW DRAINAGE CATHETER KABULA FROM SOPHYSA CONNECTED TO A DRAINAGE KI CODMAN (CODE 821735 LOT N° CTHBFM). ON (B)(6), VALVE IMPLANTATION (VALVE POLARIS FROM SOPHYSA CODE SPV200, SERIAL(B)(4)). LCR ANALYSIS OF THE REMOVED CATHETER. PART OF THE DEVICE WILL BE RETURNED FOR EVALUATION. INCIDENT REPORTED BY THE HOSPITAL TO THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109865 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CFTCZZ / CTHBFM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention