BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN SAFETY NEEDLE 22 X 1 1/2

    MDR report key: 1884531 · Received October 20, 2010

    Report

    Report Number
    1017768-2010-00023
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. THE CUSTOMER REPORTS THAT A STAFF MEMBER WAS USING THE NEEDLE WITH A 10CC SYRINGE AND THEY COULD NOT INJECT THROUGH THE NEEDLE AND AS A RESULT, THE STAFF MEMBER RECEIVED A DIRTY NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN SAFETY NEEDLE 22 X 1 1/2 SAFETY NEEDLE FMI COVIDIEN 8881850215 P010245

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK