BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED BD PEN NEEDLE

    MDR report key: 17886472 · Received October 6, 2023

    Report

    Report Number
    2243072-2023-01785
    Event Type
    Death
    Date Received
    October 6, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED ¿DECEASED. BD DIABETES CARE¿ FOR PENNEEDLE 31GX8MM UF SHORT DEVICE WITH MATERIAL NUMBER UNKNOWN AND LOT NUMBER UNKNOWN. NO PHYSICAL SAMPLES OR PHOTOS TO HELP WITH THE IDENTIFICATION OF THE MEDICAL DEVICE INVOLVED IN THIS REPORT WERE RECEIVED. EMBECTA VALUES OUR COMMITMENT TO PATIENT SAFETY AND TAKE ALL COMPLAINTS SERIOUSLY. HOWEVER, AFTER A THOROUGH REVIEW, IT HAS BEEN DETERMINED THAT THE COMPLAINT CANNOT BE FURTHER INVESTIGATED DUE TO INSUFFICIENT INFORMATION AFTER MULTIPLE, UNSUCCESSFUL OUTREACH ATTEMPTS TO THE REPORTER BY THE POST-MARKET VIGILANCE TEAM. THE INITIAL REPORT RECEIVED LACKS CRITICAL DETAILS NECESSARY FOR ANALYSIS OF CLINICAL RISKS AND A COMPREHENSIVE INVESTIGATION TO DETERMINE THAT THE EMBECTA DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED ADVERSE EVENT, INCLUDING PATIENT DEMOGRAPHICS, CLINICAL CONTEXT, AND A DETAILED EVENT DESCRIPTION. AT THIS TIME, NO FURTHER ACTIONS BY QUALITY AND MEDICAL SAFETY CAN BE PERFORMED BASED ON THE INFORMATION PROVIDED; THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. EMBECTA ACKNOWLEDGES AND APPRECIATES THE CONCERN FOR MDR REPORT, MW5145565, RECEIVED FROM FDA¿S MEDWATCH PROGRAM REGARDING AN ADVERSE EVENT ASSOCIATED WITH OUR PENNEEDLE_31GX8MM UF SHORT DEVICE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES, PHOTOS OR ADDITIONAL INFORMATION ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. E.4.: THE INITIAL REPORTER ALSO NOTIFIED THE FDA. MEDWATCH REPORT #MW5145565. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. B.3. DATE OF DEATH IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD PEN NEEDLE A DEATH OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAT# UNKNOWN, BATCH# UNKNOWN. IT WAS REPORTED BY THE CONSUMER THAT DECEASED. BD DIABETES CARE. VERBATIM: DECEASED. BD DIABETES CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD PEN NEEDLE A DEATH OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT DECEASED. BD DIABETES CARE. VERBATIM: DECEASED. BD DIABETES CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225575 UNSPECIFIED BD PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death