BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME EMERALD 19/36 SPORT W/ VT

    MDR report key: 3190162 · Received June 10, 2013

    Report

    Report Number
    1317749-2013-00177
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 REPORTS THAT THE CATHETER IS CRACKED ABOVE THE HUB. THE CATHETER WAS IMPLANTED ON (B)(6) 2010 AND REMOVED ON (B)(6) 2013. THERE WAS NO PT INJURY OR ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262139 PALINDROME EMERALD 19/36 SPORT W/ VT DIALYSIS CATHETER MPB COVIDIEN 8888119365 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK