BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAN AM ULTRA-COMFORT 1/2CC-29GX1/2

    MDR report key: 2914125 · Received December 7, 2012

    Report

    Report Number
    1915484-2012-00062
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 6, 2012
    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) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER REPORTS UPON TAKING OFF THE PROTECTIVE CAP, THE CANNULA BREAKS. THE BREAK IS OCCURRING CLOSER TO THE HUB, IT IS NOT DETACHING, IT IS BREAKING. THE CUSTOMER REPORTED THE BREAKAGES HAVE OCCURRED STRAIGHT OUT OF THE PACKAGES, PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAN AM ULTRA-COMFORT 1/2CC-29GX1/2 INSULIN SYRINGE FMF COVIDIEN 8881609350 203424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK