BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED

    MDR report key: 21653515 · Received March 20, 2025

    Report

    Report Number
    1119779-2025-00204
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 20, 2025
    Report Date
    May 27, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413866
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES A BOTTLE BROKE WHILE REMOVING IT FROM THE BACTEC FX. THE CUSTOMER HAS TRIED TO CLEAN THE INSTRUMENT BUT WAS CONCERNED ABOUT THE BLOOD THAT LEAKED WHERE THEY COULD NOT REACH. A BD FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND FOUND A SMALL AMOUNT OF LEAKAGE ON RACK C/D AND E/F IN DRAWER D. THE FSE REMOVED ALL OF THE RACKS AND CLEANED THEM WITH A 10% BLEACH SOLUTION. THE RACKS WERE REPLACED, AND THE STICKY BITS WERE CLEARED. NO INSTRUMENT ISSUES WERE DETECTED; THE UNIT IS FUNCTIONING CORRECTLY. THIS COMPLAINT IS AN UNCONFIRMED INSTRUMENT FAILURE. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FOR MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW REVEALED THERE WERE NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED ONE BACTEC BOTTLE BROKE INSIDE THE INSTRUMENT, CAUSING BLOOD/SAMPLE TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED ONE BACTEC BOTTLE BROKE INSIDE THE INSTRUMENT, CAUSING BLOOD/SAMPLE TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306776 BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown