BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 13171960 · Received January 5, 2022

    Report

    Report Number
    1119779-2021-02090
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 9, 2021
    Report Date
    June 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A FAILURE WAS REPORTED ON A BD BACTEC FX40 ( P/N 442296, S/N (B)(6). CUSTOMER REPORTED RESULTS ISSUES ON THEIR INSTRUMENT. BD REMOTE ASSISTANCE WORKED WITH THE CUSTOMER AND ADVISED THEM IT IS RECOMMENDED TO CULTURE IN THE DEVICE AGAIN. IT WAS FOUND THE SAMPLE WAS RETURNED TO THE DEVICE AFTER FIVE HOURS OR MORE CAUSING THE INSTRUMENT CULTURE DAYS RETURNING TO INITIAL VALUE EFFECTING THE RESULTS. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. THIS COMPLAINT IS NOT AN EARLY LIFE FAILURE (ELF) OF THE DEVICE. SINCE THE INSTALLATION OF THIS INSTRUMENT, THERE HAVE BEEN SERVICE EVENTS, INCLUDING PMS (PREVENTATIVE MAINTENANCE) WHICH HAVE ALTERED THE INSTRUMENT FROM ITS ORIGINAL STATE. THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD (DHR) FROM MANUFACTURING IS NOT APPLICABLE. SERVICE HISTORY REVIEW FOR THIS INSTRUMENT WAS COMPLETED AND REVEALED NO PREVIOUS COMPLAINTS RELATED TO RESULTS ISSUES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE 29 TUBES OF BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN WERE DISCOVERED TO BE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTED CONTAMINATION ON TUBES OF MEDIA 221742 WITH LOT#: 1238117.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ FX40 INSTRUMENT A FALSE POSITIVE WAS OBTAINED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615950 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 1238117 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown