BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 1843422 · Received September 22, 2010

    Report

    Report Number
    MW5017531
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6)2010, A TUNNELED DIALYSIS CATHETER WAS PLACED. PT WAS UNDERGOING DIALYSIS ON (B)(6)2010 WHERE IT WAS NOTED THAT THERE WAS A HOLE IN THE DIALYSIS CATHETER. INSPECTION OF THE CATHETER DEMONSTRATED, A PINPOINT HOLE IN ONE LIMB OF THE DIALYSIS CATHETER. A TUNNELED DIALYSIS CATHETER EXCHANGE WAS PERFORMED ON (B)(6)2010 DUE TO HOLE IN PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN PALIDROME DIALYSIS CATHETER MPB COVIDIEN NA 919130

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention