BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 5240636 · Received November 20, 2015

    Report

    Report Number
    9616656-2015-00021
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 18, 2015
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4163296. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A CONSUMER WAS INJECTING HIMSELF WITH A BD ULTRA FINE INSULIN PEN NEEDLE, THE NEEDLE BROKE OFF IN HIS ABDOMEN. THE CONSUMER WENT TO AN EMERGENCY DEPARTMENT WHERE HE WAS EVALUATED AND RECEIVED AN X-RAY. THE X-RAY VISUALIZED THE BROKEN NEEDLE IN THE FATTY TISSUE OF THE HIS ABDOMEN. THE CONSUMER THEN HAD A CONSULTATION WITH A SURGEON WHO TOLD HIM THE NEEDLE WAS NOT A THREAT AND ADVISED HIM TO HAVE A REPEAT X-RAY IN ONE MONTH. THE FOLLOW UP HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770997 31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 4163296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention