BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE

    MDR report key: 3122011 · Received May 16, 2013

    Report

    Report Number
    2243072-2013-00055
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED. COMPLAINT HISTORY CHECK: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE FIRST RELATED COMPLAINT REPORTED FOR THE DEFECT/ CONDITION ON LOT NUMBER 2283154.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THEY HAD JUST TAKEN 26 UNITS OF NOVOLOG IN THE STOMACH, WENT TO REMOVE THE NEEDLE AND IT BROKE OFF. THE CUSTOMER WAS UNABLE TO REMOVE THE NEEDLE. WENT TO THE EMERGENCY ROOM AND AN ULTRASOUND WAS PERFORMED. A NEEDLE WAS IDENTIFIED ABOUT AN INCH DOWN. INSTRUCTIONS WERE TO LEAVE THE PIECED OF NEEDLE ALONE AND IT WOULD WORK ITSELF OUT. NO FURTHER MEDICAL ATTENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216613 BD ULTRA-FINE 32G X 4 MM NANO FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention