BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAN AM RELION 1/2CC INS SYR 31X5/16

    MDR report key: 1811098 · Received August 12, 2010

    Report

    Report Number
    1915484-2010-00031
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    August 4, 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 CUSTOMER REPORTS THAT THE CANNULA DETACHED FROM THE SYRINGE DURING USE. THE END USER WAS ABLE TO REMOVE THE CANNULA AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAN AM RELION 1/2CC INS SYR 31X5/16 INSULIN SYRINGE FMF COVIDIEN 8881608041 831739

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK