BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36CM PERM CATH KIT X5

    MDR report key: 2123619 · Received June 10, 2011

    Report

    Report Number
    1317749-2011-00182
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/10/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER STATED THAT DURING THE REMOVAL OF THE CATHETER, THE CUFF CAME OFF AND THE CATHETER BROKE IN HALF. THE CUSTOMER STATES THAT WHEN THE NEPHROLOGIST ATTEMPTED TO REMOVE THE CATHETER (THAT WAS PLACED ON (B)(6) 2011) HE SAW THAT THE CATHETER STARTED STRETCHING AND SAW A TEAR. THE MD CLAMPED THE CATHETER AND HAD TO DO A CUT DOWN ON THE IJ TO REMOVE THE CATHETER. A SECOND CUT DOWN HAD TO BE DONE TO REMOVE THE OTHER HALF OF THE CATHETER. THE CUSTOMER ALSO STATES THAT THE CUFF CAME OFF OF THE CATHETER DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36CM PERM CATH KIT X5 HEMODIALYSIS CATHETER LFJ COVIDIEN 8817748001 011918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention