BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE 31G X 5MM

    MDR report key: 6106258 · Received November 16, 2016

    Report

    Report Number
    9616656-2016-00072
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULT - SAMPLE WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOT 6061902 WAS MANUFACTURED BETWEEN 16 APRIL 2016 AND 20 APRIL 2016. A REVIEW OF THE DEVICE HISTORY RECORD WAS CARRIED OUT. THE CALIBRATED CRITICAL PROCESS SETTINGS WERE REVIEWED AND NO ISSUES WERE OBSERVED. OPERATOR PROCESS INSPECTIONS WERE REVIEWED AND NO ISSUES WERE OBSERVED. QA IN PROCESS INSPECTIONS WERE REVIEWED AND NO ISSUES WERE OBSERVED. FINAL INSPECTIONS WERE REVIEWED AND NO ISSUES WERE FOUND. A REVIEW OF THE CORRECTIVE MAINTENANCE RECORDS WAS PERFORMED AND THERE WERE NO CORRECTIVE MAINTENANCE CARRIED OUT DURING THIS TIME FRAME THAT COULD CONTRIBUTE TO THIS DEFECT MODE. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE AS NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. AN ABSOLUTE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING THE SUSPECT DEVICE FROM THE INSULIN PEN, IT WASN'T DISCONNECTED PROPERLY AND THE NURSE STUCK HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757014 BD PEN NEEDLE 31G X 5MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6061902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other