BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13G X 5/16" M250 NEEDLE

    MDR report key: 3810615 · Received April 16, 2014

    Report

    Report Number
    1017768-2014-00012
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 31, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A NEEDLE. THE CUSTOMER REPORTS THE NEEDLE BROKE WHILE PERFORMING AN INJECTION. THE NEEDLE SNAPPED IN THE PATIENT'S LEG. THE CUSTOMER REPORTS THE NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233422 13G X 5/16" M250 NEEDLE NEEDLE FMI COVIDIEN 8881023516 131116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN