BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30G X 3/4 A BEVEL

    MDR report key: 3220680 · Received June 25, 2013

    Report

    Report Number
    1017768-2013-00013
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A NEEDLE. THE CUSTOMER REPORTS A PROVIDER WAS DOING A TRIGGER POINT INJECTION AND THE NEEDLE BROKE OFF TOWARDS THE BOTTOM, NEAR THE HUB AND REMAINED IN THE PT. THIS RESULTED IN THE PT HAVING TO SEE A SURGEON TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287203 30G X 3/4 A BEVEL NEEDLE FMI COVIDIEN 1188830340 710102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention