BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK DY

    MDR report key: 1842584 · Received September 16, 2010

    Report

    Report Number
    1317749-2010-00248
    Event Type
    Other
    Date Received
    September 16, 2010
    Report Date
    September 3, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS GUIDEWIRE. THE CUSTOMER REPORTED, A TRIPLE LUMEN MAHURKAR WAS PLACED SOMETIME IN APRIL, AND THE GUIDEWIRE WAS NOT REMOVED AFTER PLACEMENT. GUIDEWIRE WAS REMOVED ON (B)(6) 2010 WHEN INTERVENTIONAL RADIOLOGY SPOTTED THE OBJECT WHILE PLACING A PERMANENT CATHETER. (B)(6) HAD TO ACCESS PT'S TUNNELED CATHETER AND RETRIEVE THE GUIDEWIRE THROUGH PT'S RIGHT JUGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DY HEMODIALYSIS GUIDEWIRE DQX COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other