BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELL INSULIN 1/2ML 29GX1/2

    MDR report key: 4850313 · Received June 17, 2015

    Report

    Report Number
    1915484-2015-00024
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 26, 2015
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. THERE WERE NO SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED ISSUE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION CONTINUED. A POSSIBLE ROOT CAUSE MAY BE DUE TO DAMAGE TO THE SHIELD OR LOCK INSERT LOCKING FEATURES. ANOTHER POSSIBLE ROOT CAUSE MAY BE DUE TO EXCESSIVE ADHESIVE IN THE LOCK INSERT TANGS. THE MANUFACTURING PLANT MAINTAINS MATERIAL VERIFICATION PROCESSES. THE RESIN, LOCK INSERT AND ADHESIVE MUST PASS AN INSPECTION AND CERTIFICATION REVIEW BEFORE THEY ARE RELEASED TO THE FLOOR FOR PRODUCTION. THE MANUFACTURE OF THE MOLDED BARREL AND SHIELD IS CONDUCTED WITHIN A VALIDATED PROCESS. THE MACHINE THE SYRINGE IS ASSEMBLED ON IS EQUIPPED WITH A VISION SYSTEM WHICH INSPECTS FOR ADHESIVE PRESENCE TO ENSURE SUFFICIENT ADHESIVE IS DISPENSED TO RETAIN THE CANNULA AND LOCK INSERT WITHOUT OVERSPILL OR EXCESSIVE ADHESIVE DISPENSE. THE SAFETY SHIELD IS EXERCISED DURING INSTALLATION TO ENSURE PROPER MOVEMENT. DURING MANUFACTURING, ASSOCIATES VISUALLY INSPECT SYRINGE ASSEMBLIES AND TEST PRODUCT TO ENSURE THE REQUIREMENTS OF THE QUALITY INSPECTION STANDARD ARE MET. FUNCTIONAL TESTING IS CONDUCTED THROUGHOUT THE PRODUCTION RUN TO ENSURE SPECIFICATION REQUIREMENTS FOR SHIELD ACTIVATION FORCE, SHIELD DETACH FORCE AND SHIELD COMPRESSION FORCE HAVE BEEN MET. A LOT CANNOT BE RELEASED UNLESS IT PASSES VISUAL AND PHYSICAL TESTING REQUIREMENTS. THE PLASTIC SHIELD ON THE SAFETY SYRINGE IS DESIGNED TO SLIDE FORWARD TO COVER THE NEEDLE TO PREVENT NEEDLE STICKS AFTER USE. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS NOT DEEMED NECESSARY AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    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) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. THE CUSTOMER STATES THAT THE NURSE HAD DELIVERED INSULIN VIA MAGELLAN INSULIN AND PROCEEDED TO ACTIVATE THE SAFETY. THE NURSE BELIEVED THAT THE SAFETY WAS ACTIVATED AS SHE PUSHED ALL THE WAY UP AND IT WOULD NOT GO ANY FARTHER. WHEN SHE WENT TO DISPOSE OF NEEDLE IN THE SHARPS CONTAINER, SHE WAS STUCK BY THE NEEDLE. THE NURSE STILL DISPOSED OF THE SAFETY NEEDLE IN SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394977 MAGELL INSULIN 1/2ML 29GX1/2 SAFETY NEEDLE FMI COVIDIEN 8881892950 507869X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other