BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 3222150 · Received July 2, 2013

    Report

    Report Number
    1317749-2013-00216
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE STAFF WENT TO FLUSH THE CATHETER AND DISCOVERED A HOLE. THE CATHETER WAS IMPLANTED ON (B)(6) 2012. THE CATHETER WILL BE PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300967 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145014 215235X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN