BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOJECT STANDARD HYPODERMIC NEEDLE

    MDR report key: 4080791 · Received September 7, 2014

    Report

    Report Number
    MW5038104
    Event Type
    Injury
    Date Received
    September 7, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING COVIDIEN MONOJECT STANDARD HYPODERMIC NEEDLES, 27GX1-1/2", (B)(4), LOT 323198X. I HAVE BEEN INSTRUCTED TO USE THESE FOR DEEP-IM INJECTIONS OF DIPHENHYDRAMINE IN THE LATERAL THIGH OR GLUTEAL REGION, AND HAVE DONE SO FOR YEARS. ON (B)(6) 2014, I WAS SELF-INJECTING INTO THE LEFT THIGH, AND THE NEEDLE DISCONNECTED FROM THE HUB, REMAINED LODGED, UNEXPOSED, INSIDE MY THIGH. I WAS FORCED TO VISIT A LOCAL ED, AND WAS EVENTUALLY SENT TO ORTHOPEDIC SURGERY ((B)(6) 2014), WHERE IT WAS REMOVED AS AN EMERGENCY OPERATION EARLY IN THE MORNING OF (B)(6). IT APPEARS THE NEEDLE ASSEMBLY WAS DEFECTIVE, SINCE THE NEEDLE DID MIGRATE SEVERAL INCHES WITHIN THE THIGH. HE NOTED THAT IT MIGHT HAVE BEEN LIFE-THREATENING, HAD IT MIGRATED A GREATER DISTANCE, PARTICULARLY TO THE HEART, LUNGS, OTHER INTERNAL ORGANS, OR SIMPLY PIERCED A VESSEL, RESULTING IN INTERNAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547308 MONOJECT STANDARD HYPODERMIC NEEDLE NONE FMI COVIDIEN REF: 1188827112 323198X

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| O| R| S