BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON, DICKINSON & CO. (SPARKS)

    MDR report key: 16402639 · Received February 20, 2023

    Report

    Report Number
    1119779-2023-00132
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 26, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00132 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INVESTIGATION SUMMARY: BD QUALITY HAS REVIEWED THE COMPLAINT, SERVICE ACTIVITIES, AND ADVERSE EVENT QUESTIONS. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. ADDITIONAL INVESTIGATION WILL BE PERFORMED IF AN ACTIONABLE LEVEL IS REACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BECTON, DICKINSON & CO. (SPARKS) THAT THERE WAS A LEVELING FOOT FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY ROULETTE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BECTON, DICKINSON & CO. (SPARKS) THAT THERE WAS A LEVELING FOOT FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY ROULETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319356 BECTON, DICKINSON & CO. (SPARKS) SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown