BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1032916 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02158
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Report Date
    March 26, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PIECES OF CATHETER WERE RETURNED FOR ANALYSIS: A STRAIGHT PUMP CONNECTOR AND 22.3 CM PIECE; A 24.6 CM PIECE; A 17.0 CM PIECE TO THE DISTAL TIP. FINAL DEVICE ANALYSIS REVEALED A HOLE IN THE CATHETER CAUSED BY THE PUMP CONNECTOR PIN.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED BY THE MFR FOR ANALYSIS WITH NO ADD'L DEVICE TROUBLESHOOTING OR CLINICAL DATA. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYS INDICATES MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 L74641

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED| EXPLANTED| IMPLANTED| PUMP MODEL # 8627L18| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK