BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 G X 5 MM BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 6941943 · Received October 11, 2017

    Report

    Report Number
    9616656-2017-00127
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 6, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR OF LOT 7061486 WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. MANUFACTURING RECORDS WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. RETAIN SAMPLES AND RETURN SAMPLES WERE REVIEWED, ALL TEST DATA MEET SPECIFICATION. BASED ON THE INVESTIGATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE FOUND. THE INCIDENT HAS BEEN DETERMINED NOT TO BE MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 31 G X 5 MM BD MICRO-FINE¿ PEN NEEDLE BROKE OFF INTO THE PATIENT¿S ABDOMEN WHEN GETTING A HOME INJECTION BY HIS PARENT. THE PATIENT WAS TAKEN TO THE HOSPITAL TO HAVE THE NEEDLE SURGICALLY REMOVED. NO OTHER INFORMATION WAS PROVIDED REGARDING MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722383 31 G X 5 MM BD MICRO-FINE¿ PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7061486

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Required Intervention