BEUDAMED
    FDA Adverse Event Other Summary report: N

    1CC SAF SYR ETB 25X 5/8

    MDR report key: 3855605 · Received May 28, 2014

    Report

    Report Number
    1915484-2014-00020
    Event Type
    Other
    Date Received
    May 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. 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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN SYRINGE. THE CUSTOMER REPORTS THERE WAS A NEEDLE STICK TO A NURSE. THE CUSTOMER REPORTED THE NURSE ADMINISTERED THE MEDICATION, SHE THEN PULLED UP ON THE SAFETY SHIELD, AND WHEN SHE MOVED IT TO THE OTHER HAND, IT RETRACTED. ADD'L F/U WITH THE CUSTOMER WAS CONDUCTED AND THE SAFETY SHIELD ACTIVATION METHOD WAS CLARIFIED. WHEN THE SAFETY SHIELD IS EXTENDED FORWARD, IT IS NOT IN THE FINAL LOCK POSITION. IN ORDER TO LOCK THE SHIELD, IT MUST BE TWISTED TO ITS FINAL LOCK POSITION IN EITHER DIRECTION AND A CLICK WILL BE HEARD. THE NURSE FOLLOWED EMPLOYEE EXPOSURE PROTOCOL. THE CUSTOMER FURTHER REPORTED THAT THERE ARE NO SAMPLES AVAILABLE FOR EVAL AS THE PRODUCT WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314659 1CC SAF SYR ETB 25X 5/8 INSULIN SYRINGE FMF COVIDIEN 8881511235 229821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other