BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR 13.5FRX19.5CM SE KIT

    MDR report key: 2913901 · Received December 6, 2012

    Report

    Report Number
    1317749-2012-00311
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. (B)(4).

    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 STATED THAT WHEN TRYING TO REMOVE THE GUIDE WIRE, IT WAS DIFFICULT AND THE GUIDE WIRE FRAYED. THE VASCULAR ACCESS WAS LOST IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR 13.5FRX19.5CM SE KIT DIALYSIS CATHETER MPB COVIDIEN 8888135191 204708X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK