BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC.

    MDR report key: 8483088 · Received April 4, 2019

    Report

    Report Number
    2411236-2019-00002
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 15, 2019
    Manufacturer
    SHANGHAI KINDLY ENTERPRISE DG
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE RIGHT HIP OF A (B)(6) MALE PATIENT WAS PREPPED FOR GREATER TROCHANTERIC BURSA INJECTION. THE INJECTION, CONSISTING OF A 2CC BETAMETHASONE, 1.5CC LIDOCAINE AND 1.5CC AND 1.5CC BUPIVACAINE WAS PERFORMED USING A 5CC SYRINGE AND 1.5 INCH NEEDLE. THE PATIENT WAS REPORTED TO TOLERATE THE PROCEDURE WELL. THE NEEDLE AND SYRINGE UTILIZED TO PERFORM THE INJECTION WAS INSPECTED AND IT WAS NOTED THAT THE NEEDLE HAD BROKEN FREE FROM THE HUB. THE HUB REMAINED ATTACHED TO THE LUER LOCK SYRINGE. THE NEEDLE WAS BELIEVED TO REMAIN INSIDE THE PATIENT'S HIP. THE PATIENT WAS INSTRUCTED TO GO TO THE HOSPITAL TO HAVE THE NEEDLE REMOVED. THE PATIENT WENT TO EMERGENCY ROOM FOR MEDICAL ASSISTANCE; HOWEVER, HE WAS SENT HOME SINCE NO ONE WAS AVAILABLE TO PERFORM THE REQUIRED PROCEDURE. ON (B)(6) 2019 THE PATIENT VISITED AN ORTHOPEDIC WHO ADVISED HIM THE ISSUE WAS BEYOND HIS SCOPE AND HE COULD NOT HELP HIM REMOVE THE NEEDLE. ON (B)(6) 2019 THE PATIENT VISITED A GENERAL SURGEON WHO WAS ABLE TO REMOVE THE NEEDLE. THE NEEDLE HAD TRAVELED FURTHER INTO THE MUSCLE OVER THE SIX (6) DAYS SINCE THE INCIDENT OCCURRED AND TOOK FOUR (4) HOURS TO REMOVE. THE PATIENT IS CURRENTLY RECOVERING AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278604 HENRY SCHEIN INC. NEEDLE DISPOSABLE FMI SHANGHAI KINDLY ENTERPRISE DG 20180120

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other