BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSPECIFIED BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 17561113 · Received August 16, 2023

    Report

    Report Number
    2243072-2023-01464
    Event Type
    Death
    Date Received
    August 16, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 4, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: 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. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. B.4. DATE OF DEATH: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER THE UNSPECIFIED BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS USED ON THEM TO DELIVER ORAL MEDICATION. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TO GIVE SOME BACKGROUND, THIS IS LINKED TO A COMMUNICATION WE HAVE RECEIVED CONCERNING USE OF THE SAF-T-INTIMA DEVICE TO DELIVER ORAL MEDICATION WHICH HAS RESULTED IN THE DEATH OF 2 PATIENTS WITHIN A TRUST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738003 UNSPECIFIED BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death