BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TNCKHOFF STR 2CUFF BENT 130

    MDR report key: 3210107 · Received June 27, 2013

    Report

    Report Number
    1317749-2013-00199
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 DURING USE ON A PT AND AFTER 553 DAYS OF USE, THE UPPER PART OF THE CUFF INSIDE THE CAPD CATHETER BROKE. THERE WAS NO PT HARM. THE PT WAS INTUBATED ON (B)(6) 2011. IN THE BEGINNING OF (B)(6) 2013, THE PT HAS NOTICED THE CLYSIS TIME OF DIALYSATE SOLUTION TOOK LONGER. ON (B)(6) 2013, THE PT VISITED THE HOSPITAL SINCE DRAINAGE OF SOLUTION WAS FAILING. ON THE NEXT DAY, THE DOCTOR CONFIRMED LEAK FROM THE CATHETER ON THE INNER CUFF AND THE CATHETER WAS REPLACED ON THE FOLLOWING DAY OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293288 TNCKHOFF STR 2CUFF BENT 130 DIALYSIS CATHETER MPB COVIDIEN 8888422154 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK