BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 15417343 · Received September 14, 2022

    Report

    Report Number
    15417343
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 12, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSING WENT TO INJECTION THE VARCIELLA VACCINE SUB-Q IN THE LEFT UPPER LEG. THE NEEDLED WAS IN THE SUB-Q AREA, WHEN NURSING WENT TO INJECTION THE IMMUNIZATION, THE NEEDLE DISCONNECTED FROM THE HUB AND SYRINGE. NURSING DISCUSSED WITH DR., HE ADVISED THAT PATIENT RECEIVE ANOTHER VARICELLA INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644096 JELCO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 4291 4028603

    Patients

    Seq Age Sex Outcome Treatment
    1 360 DA Male