BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINFROME 55-73 KIT/WSLOT

    MDR report key: 1881634 · Received October 20, 2010

    Report

    Report Number
    1317749-2010-00283
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/19/2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CATHETER HAD A LEAK IN ONE OF THE EXTENSIONS. THE PRODUCT CAN BE USED WITH INVERSE FLOW ONLY. THE CATHETER NEEDED TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINFROME 55-73 KIT/WSLOT HEMODIALYSIS CATHETER MSD COVIDIEN 8888145018 929158

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK