BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPO NEEDLE 18X1 A BEVEL 250E NDL

    MDR report key: 2233208 · Received July 22, 2011

    Report

    Report Number
    1017768-2011-00021
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HYPODERMIC NEEDLE. THE CUSTOMER STATES THAT WHEN DRAWING FLUID FROM A VIAL, THE NEEDLE SEPARATED FROM THE HUB. THE CUSTOMER STATED THIS WAS DURING THE FIRST DRAW FROM THE VIAL. NO PT INVOLVEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPO NEEDLE 18X1 A BEVEL 250E NDL HYPODERMIC NEEDLE FMI COVIDIEN 1188818100 110850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK