BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGELL INSULIN 1/2ML 29GX1/2

    MDR report key: 3190164 · Received June 17, 2013

    Report

    Report Number
    1915484-2013-00015
    Event Type
    Other
    Date Received
    June 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 30, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE AN INSULIN SAFETY SYRINGE. THE CUSTOMER REPORTS THE NURSE WAS ADMINISTERING AN INSULIN INJECTION TO THE ABDOMEN AREA OF A RESIDENT. SHE STATED THAT SHE THOUGH SHE HAD ACTIVATED THE SAFETY MECHANISM AND HEARD THE ACTIVATION CLICK, SHE WENT TO COVER THE RESIDENT BACK UP, AND WHEN SHE BRUSHED AGAINST THE END OF THE SAFETY COVER, THE NEEDLE WAS EXPOSED AND SHE STUCK HERSELF. TREATMENT FOR THE NEEDLE STICK INJURY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274126 MAGELL INSULIN 1/2ML 29GX1/2 INSULIN SAFETY SYRINGE FMF COVIDIEN 8881892950 304236X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other