BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBAR EXTERNAL DRAINAGE KIT

    MDR report key: 5729113 · Received June 16, 2016

    Report

    Report Number
    1226348-2016-10430
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    May 23, 2016
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC.
    Product Code
    JXG
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE 403MM OF CATHETER WAS VISUALLY INSPECTED; IT WAS NOTED THAT ONE END OF THE CATHETER WAS JAGGED AND THE OTHER END WAS CLEAN CUT. A RESEARCH FOR RELATED COMPLAINTS WAS DONE FOR PRODUCT CODE 82-1706 FOR THE LAST 2 YEARS, 3 ISSUES FOUND INCLUDING THIS ONE, DEVICES NOT RETURNED, COMPLAINTS COULD NOT BE CONFIRMED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE PRODUCT CODE 82-1706 WITH LOT CTPB53, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 28TH JANUARY 2016. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE, THIS HOWEVER COULD NOT BE DETERMINED. AS NOTED IN THE IFU CATHETERS HAVE A LOW TEAR / CUT RESISTANCE. 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

    (B)(4) UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PIECE OF THE CATHETER BROKE OFF IN THE PATIENT. SURGEON REMOVED AND PLACED ANOTHER CATHETER. NO DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385197 CODMAN LUMBAR EXTERNAL DRAINAGE KIT CNS EXTERNAL DRAINAGE SYSTEM JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. CTPB53

    Patients

    Seq Age Sex Outcome Treatment
    1