BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME EMERALD 23/40 KIT

    MDR report key: 2890599 · Received November 21, 2012

    Report

    Report Number
    1317749-2012-00299
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 6, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS A BROKEN PALINDROME H 23CM CATHETER. THE CATHETER HAS A SMALL HOLE OR BREAKAGE WHICH IS CAUSING A LEAK LOCATED JUST BELOW THE BACK END HUB, IN THE WHITE AREA. THE CATHETER WAS INSERTED ON (B)(6), 2012. IT WAS NOTED TO BE BROKEN ON (B)(6), 2012. THE CATHETER WAS PULLED AND REPLACED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME EMERALD 23/40 KIT DIALYSIS CATHETER MSD COVIDIEN 8888145044C 034310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK