BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6202547 · Received December 23, 2016

    Report

    Report Number
    9616656-2016-00083
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    December 9, 2016
    Report Date
    January 25, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6033997. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HE WAS RECAPPING A 31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE, THE NEEDLE PENETRATED IS PINK CAP, AND HE STUCK HIS FINGER. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853121 31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6033997

    Patients

    Seq Age Sex Outcome Treatment
    1 Other