BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 3242711 · Received July 16, 2013

    Report

    Report Number
    MW5030965
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MALLIN CKROOT INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF PAINFUL NEEDLE INSERTION DURING INTRATHECAL BACLOFEN PUMP REFILL. UPON WITHDRAWAL OF NEEDLE, A SMALL FRAGMENT OF FOREIGN SUBSTANCE (METALLIC BURR?) WAS ROUND ON THE END OF THE NEEDLE WAS RETAINED FOR ANALYSIS. MANUFACTURER NOTIFIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330503 COVIDIEN NEEDLE DYB MALLIN CKROOT INC. 2013012490

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention