BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS SAF SYR 1/2 CC 29X1/2IN 100 HRDPK

    MDR report key: 1952723 · Received January 4, 2011

    Report

    Report Number
    1915484-2011-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 30, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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 SAFETY SHIELD WAS BEING PUSHED FORWARD TO ACTIVATE WHEN THE SHIELD CAME LOOSE AND SEPARATED FROM THE SYRINGE. AS A RESULT, THE CLINICIAN RECEIVED A DIRTY NEEDLE STICK. IN RESPONSE TO THIS INCIDENT, A BANDAGE WAS APPLIED TO THE STICK AREA AND THE CLINICIAN FOLLOWED THE FACILITY'S NEEDLE STICK PROTOCOL WHICH INCLUDES BASELINE TESTING FOR BLOOD BORNE PATHOGENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS SAF SYR 1/2 CC 29X1/2IN 100 HRDPK INSULIN SYRINGE MEG COVIDIEN 8881511136 022614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN