BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER MICRO BLUNT CANNULA, NON0CORING SAFETY NEEDLE

    MDR report key: 4173287 · Received September 25, 2014

    Report

    Report Number
    2183502-2014-00715
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE EVAL RESULTS.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE CLINICIAN WAS HAVING DIFFICULTY ENGAGING THE NEEDLE INTO THE SAFETY MECHANISM AND SUSTAINED A NEEDLE STICK. THE CLINICIAN IS BELIEVED THE BE RECEIVING TREATMENT IN A MANNER CONSISTENT WITH THE HOSPITAL'S INTERNAL PROTOCOL FOR NEEDLE-STICK INJURIES. NO ADVERSE EFFECTS TO PT OR USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597787 GRIPPER MICRO BLUNT CANNULA, NON0CORING SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other