BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE-II INSULIN SYRINGE

    MDR report key: 3800243 · Received May 1, 2014

    Report

    Report Number
    2243072-2014-00072
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR REP SAMPLES HAS BEEN MADE AS THE ACTUAL UNIT INVOLVED IS NOT AVAILABLE FOR EXAMINATION. IF SAMPLES ARE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CONSUMER INJECTED WITH THIS SYRINGE INTO THE RIGHT SIDE OF HIS STOMACH. AFTER THE INSULIN WAS INJECTED, AND THE SYRINGE WAS PULLED OUT, THE NEEDLE WAS MISSING. THE CUSTOMER FEELS THE NEEDLE IS INSIDE THE SKIN, HOWEVER, THE DOCTORS FEEL IT FELL OUT. AN ULTRASOUND WAS COMPLETED, BUT THE NEEDLE WAS NOT FOUND. AN X-RAY WAS ALSO COMPLETED; SOMETHING WAS SEEN, BUT THE NEEDLE WAS NEVER FOUND. NO FURTHER MEDICAL ATTENTION IS BEING RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261068 BD ULTRA FINE-II INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD 2129345

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention