BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN* LUMBAR CATHETER KIT

    MDR report key: 2251821 · Received September 16, 2011

    Report

    Report Number
    1226348-2011-00351
    Event Type
    Injury
    Date Received
    September 16, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K964923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AND NO LOT INFORMATION WAS MADE AVAILABLE. AS SUCH, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OR TO EVALUATE MANUFACTURING RECORDS FOR THE SUBJECT DEVICE. NO CORRECTIVE ACTION OR FOLLOW UP IS POSSIBLE. COMPLAINT WILL BE CLOSED WITHOUT ANY FURTHER ACTION. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT CODE (CATHETER HAD SHEARED), THEREFORE; IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. DEVICE UNAVAILABLE.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT DOCTOR HAD TROUBLE OBTAINING CSF UPON NEEDLE INSERTION. THE NEEDLE SIZE WAS CHANGED, WHICH DID NOT HELP. WHEN CHANGED BACK TO THE ORIGINAL NEEDLE AND UPON PULLING BACK THE NEEDED HE REALIZED THE CATHETER HAD SHEARED. AS A RESULT THE DOCTOR CONVERTED TO OPEN CATHETER INSERTION AND REMOVED SHEARED CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN* LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1