BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED INSULIN PEN NEEDLE

    MDR report key: 6936953 · Received October 10, 2017

    Report

    Report Number
    2243072-2017-00182
    Event Type
    Death
    Date Received
    October 10, 2017
    Date of Event
    September 29, 2017
    Report Date
    October 12, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE IF THE REPORTED DEVICE IS A BD PRODUCT OR WHERE IT WAS MANUFACTURED. THEREFORE, BD (B)(6) HAS BEEN LISTED. THE FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DATE OF DEATH: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN INVESTIGATION SUMMARY: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. 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. *OF NOTE, DUE TO THE NATURE OF HOW THIS INFORMATION WAS REPORTED TO BD, IT IS UNKNOWN IF THE REPORTED DEVICE IS A BD PRODUCT AS THERE IS NO MENTION OF BD OR THE SPECIFIC INSULIN INJECTED WHICH COULD THEN BE LINKED TO A BD NEEDLE. ADDITIONAL INFORMATION IS NOT AVAILABLE AND THEREFORE A CONCLUSION CANNOT BE DRAWN AS TO WHETHER THE UNKNOWN DEVICE MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (TYPE OF REPORT) FROM 5 DAY TO 30 DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER WAS STARTED ON INSULIN FOR TYPE II DIABETES MELLITUS. PATIENT WAS NOT TAUGHT TO REMOVE THE CAP FROM THE UNSPECIFIED INSULIN PEN NEEDLE, AND WAS HOSPITALIZED WITH DKA WITHIN DAYS. PATIENT WAS RE-EDUCATED, BUT NOT TAUGHT TO REMOVE THE SMALL CAP FROM THE INSULIN NEEDLES. PATIENT WAS READMITTED TO HOSPITAL WITH DKA WITHIN DAYS AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716272 UNSPECIFIED INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death