BEUDAMED
    FDA Adverse Event Other Summary report: N

    1/2CC E100 SAF 29X1/2

    MDR report key: 3092486 · Received April 29, 2013

    Report

    Report Number
    1915484-2013-00009
    Event Type
    Other
    Date Received
    April 29, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 04/26/2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH SAFETY NEEDLE. THE CUSTOMER REPORTS WHEN ACTIVATING THE SHIELD, THE SHIELD LOCKED AND HAD RESISTANCE, AS A RESULT THE EMPLOYEE APPLIED MORE PRESSURE AND HIS HAND SLIPPED AND HIT THE NEEDLE, CAUSING A DIRTY NEEDLE STICK. THE INCIDENT OCCURRED FOLLOWING AN INSULIN SHOT. THE NURSE WAS SEEN BY (B)(6); BLOOD TESTS WERE CONDUCTED ACCORDING TO HOSPITAL PROTOCOL. THE BLOOD TESTS WERE NEGATIVE ON THE FIRST TEST AND THE TEST WILL BE REPEATED AT 90 DAYS AND THEN AGAIN AT 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184978 1/2CC E100 SAF 29X1/2 SAFETY NEEDLE FMI COVIDIEN 8881511136 216433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK