BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 2963034 · Received January 24, 2013

    Report

    Report Number
    1317749-2013-00046
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES DURING THE PLACEMENT OF CATHETER, IT BROKE AND BLOOD LEAKAGE OCCURRED. THE CUSTOMER REPORTS THE CATHETER BROKE AT THE CONNECTION WITH THE ARTERY AND SILICONE WHILE INSIDE THE PT'S BODY. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35117 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145014 110387

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK