BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAN AM GOODNEIGH INS SYR 31G X1CC

    MDR report key: 1935122 · Received December 6, 2010

    Report

    Report Number
    1915484-2010-00044
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 2, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE END USER STATES THAT THE CANNULA BROKE OFF IN A BOTTLE OF INSULIN. AFTER THE END USER INSERTED THE CANNULA INTO THE INSULIN BOTTLE TO WITHDRAW INSULIN, SHE NOTICED THE CANNULA WAS MISSING. THE END USER STATES THAT SHE BELIEVES THE CANNULA IS INSIDE THE INSULIN BOTTLE ALTHOUGH SHE IS NOT CERTAIN BECAUSE OF THE COLOR OF THE INSULIN. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAN AM GOODNEIGH INS SYR 31G X1CC INSULIN SYRINGE FMF COVIDIEN 8881608240 925205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK