BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 17760785 · Received September 15, 2023

    Report

    Report Number
    2243072-2023-01658
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT 5 EAST AND 5 WEST LABOR & DELIVERY NURSES COMPLAINED OF AIR IN LINE ISSUES. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE MODEL AND LOT NUMBERS ARE UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET HAD AIR BUBBLES/AIR IN LINE. THIS IS REPORT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: 5 EAST AND 5 WEST LABOR & DELIVERY NURSES COMPLAINED OF AIR IN LINE ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET HAD AIR BUBBLES/AIR IN LINE. THIS IS REPORT 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: 5 EAST AND 5 WEST LABOR & DELIVERY NURSES COMPLAINED OF AIR IN LINE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299768 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown