BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 16515868 · Received March 9, 2023

    Report

    Report Number
    3014334038-2023-00029
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 16, 2023
    Report Date
    July 12, 2023
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    UDI-DI
    10886704040811
    PMA / PMN Number
    K964923
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LUMBAR CATHETER ((B)(4)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - A VISUAL INSPECTION CONFIRMED A BROKEN/TORN DRAIN TUBE, UNABLE TO PERFORM FUNCTIONAL TESTING DUE TO BROKEN PRODUCT, AND THE DEVICE DID NOT MEET THE SPECIFICATIONS. THEREFORE, THE COMPLAINT CONDITION COULD BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. PRODUCT WAS RECEIVED FOR ANALYSIS AND THE INVESTIGATION COULD CONFIRM THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A LUMBAR CATHETER KIT (ID 821707) DRAIN BROKE IN PATIENT UPON INSERTION AND THE PATIENT WAS IMAGED UNDER FLUOROSCOPY, AN INCISION WAS MADE IN THE LUMBAR REGION TO REMOVE THE BROKEN PIECE, THEN IRRIGATED OUT AND CLOSED. THE PATIENT WAS IMAGED AFTER AND CONFIRMED ALL PIECES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163746 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG RAYNHAM 82-1707 J2604M 10886704040811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown