BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 3870125 · Received June 12, 2014

    Report

    Report Number
    1226348-2014-11702
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS RETURNED, AND AFTER ETO DECONTAMINATION, IT WAS VERIFIED THAT THE RETURNED CODMAN LUMBAR CATHETER P/N 82-1707; LOT # 238595 WAS ATTACHED TO A NON-CODMAN DRAINAGE SYSTEM. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE CATHETER WAS DAMAGE WITH A CUT AT APPROXIMATELY 1 1/4" FROM THE DISTAL TIP, AND ALSO AT THE PROXIMAL END OF THE CATHETER WITH TWO SMALL HOLES WHERE THE CONNECTOR AND SUTURE ARE LOCATED. COMPLAINT IS CONFIRMED. THE CAUSE(S) OF THE DAMAGES COULD NOT BE FULLY DETERMINED; HOWEVER, IT APPEARS TO HAVE BEEN INADVERTENTLY DAMAGE BY THE CUSTOMER DURING USE. A LOT HISTORY RECORDS REVIEW FOR P/N 80-1707; LOT # 238595 WAS CONDUCTED AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON MAY 31, 2012. A COMPLAINTS RECORDS REVIEW WAS ALSO CONDUCTED, AND IT WAS VERIFIED THAT AT THE PRESENT DATE THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER, FOR THIS TYPE OF ISSUE, AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINT. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). DURING DRAINAGE'S REMOVAL, THE SURGEON NOTED A LACERATION NOT PRESENT BEFORE ITS APPLICATION. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348860 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 238595

    Patients

    Seq Age Sex Outcome Treatment
    1