BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 4130112 · Received September 30, 2014

    Report

    Report Number
    1226348-2014-12015
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 26, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CODMAN LUMBAR DRAINAGE CATHETER P/N 82-1707; LOT # 299206 WAS RECEIVED FOR EVALUATION. AS RECEIVED AND AFTER ETO DECONTAMINATION, THE CATHETER WAS EXAMINED UNDER APPROPRIATE MAGNIFICATION. THE BROKEN END SURFACE OF THE CATHETER IS IRREGULARLY TORN (IN A SPIRAL CONFIGURATION), INDICATING THAT IT MAY HAVE BEEN IN CONTACT WITH A SHARP OBJECT AND SUBJECTED TO SOME STRETCHING AT THE SAME TIME. HOWEVER, THE COMPLETE CAUSE(S) OF THE BREAKAGE COULD NOT BE FULLY DETERMINED. LOT HISTORY RECORDS REVIEW FOR P/N 82-1707; LOT # 299206 WAS CONDUCTED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON NOVEMBER 20, 2012. A COMPLAINTS RECORDS REVIEW WAS ALSO CONDUCTED, AND IT WAS VERIFIED THAT THIS IS THE (B)(4) COMPLAINT REPORTED FOR THIS LOT # 299206. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT WHEN THE SURGEON WAS REMOVING THE DEVICE IT SHEARED OFF 3 TO 4 MM FROM THE DISTAL TIP. PIECE REMAINS IN THE PATIENT. SURGEON DOES NOT FEEL IT IS NECESSARY TO EXPLORE TO REMOVE THE DEVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608229 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 299206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention