BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T WING BLOOD COLLECTION & INFUSION SET

    MDR report key: 3131372 · Received May 13, 2013

    Report

    Report Number
    2183502-2013-00219
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE NEEDLE DID NOT FULLY ENGAGE INTO THE SAFETY DEVICE CAUSING A NEEDLE-STICK INJURY WITH THE USER. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211826 SAF-T WING BLOOD COLLECTION & INFUSION SET NEEDLE, BLOOD COLLECTING FMI SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention