BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 3542311 · Received December 30, 2013

    Report

    Report Number
    1226348-2013-37152
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    December 27, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 A VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE CATHETER WAS RECEIVED WITHOUT THE GUIDE WIRE AND THE PLASTIC CONNECTOR WAS ATTACHED TO THE CATHETER. SOME DEBRIS WAS OBSERVED AT TWO OF THE HOLES AT THE DISTAL END OF THE CATHETER. THE DEBRIS IS CONSISTENT IN APPEARANCE WITH BIOLOGICAL DEBRIS. NO OCCLUSIONS WERE NOTED IN THE CATHETER WHEN THE CATHETER WAS IRRIGATED. THE LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE CLINICIAN HAD DIFFICULTY USING THE LUMBAR KIT. THE SURGEON GETS GOOD FLOW THROUGH THE TUBING NEEDLE, BUT NO TO MINIMAL FLOW THROUGH THE CATHETER. THE PATIENT IS BEING MONITORED. THE SURGEON WANTS TO CONDUCT A REVISION USING PRODUCT CODE 82-1706 AND WILL OBTAIN A CATHETER FROM ANOTHER ACCOUNT. ADDITIONAL INFORMATION FROM THE SALES REP STATED THAT ONCE THE REP PICKED UP THE DEVICE, THE SURGEON DECIDED NOT WANT TO USE IT. HE DECIDED TO USE PRODUCT CODE 82-1707 AND HAD THE SAME PROBLEM. HE CONCLUDED THAT HE DOES NOT BELIEVE THERE WAS AN ISSUE WITH THE CATHETER, RATHER A PATIENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679658 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention