BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INTRODUCER, 7F 7CM

    MDR report key: 2960996 · Received January 15, 2013

    Report

    Report Number
    2953189-2013-00008
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 9, 2012
    Report Date
    January 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH MICRO INTRODUCER, 7F 7CM. THE CUSTOMER STATES THAT A DISTAL PIECE OF THE 45CM GUIDEWIRE BROKE OFF IN THE PT. CUSTOMER STATES THAT PHYSICIAN HAD TO MAKE AN INCISION AND EXTRACT THE PIECE OF GUIDEWIRE OUT OF THE PT. THE PT WAS SUTURED UP WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23086 MICRO INTRODUCER, 7F 7CM MICRO INTRODUCER, 7F 7CM DYB COVIDIEN MIS-7F07 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK