BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 2061119 · Received February 10, 2011

    Report

    Report Number
    1226348-2011-00050
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    November 25, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K964923
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A F/U REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A F/U REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    MEDWATCH REPORT EXPLAINS A NURSE WAS ASSISTING THE ANESTHESIOLOGIST IN REMOVING THE PT'S LUMBAR DRAIN. WHEN THE NURSE WAS HELPING TO TURN THE PT TO ASSIST THE ANESTHESIOLOGIST WITH THE DRAIN REMOVAL, THE DRAIN TUBING BROKE, AND THE ANESTHESIOLOGIST WAS UNABLE TO REMOVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN LUMBAR CATHETER KIT NONE JXG CODMAN & SHURTLEFF, INC. NA CLFDRJ

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR