BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    MDR report key: 18024234 · Received October 27, 2023

    Report

    Report Number
    1119779-2023-01188
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 12, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2312543, D4. MEDICAL DEVICE EXPIRATION DATE: 05-MAY-2024. H4. DEVICE MANUFACTURE DATE: 08-NOV-2022. 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: THE BATCH HISTORY RECORDS (BHR) FOR BATCHES 2312543 AND 3032615 ARE SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON EITHER BATCH 2312543 OR 3032615 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 2312543 (100 TUBES) AND 3032615 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS SEEN IN 100/100 TUBES FROM BATCH 2312543 AND 100/100 TUBES FROM BATCH 3032615. FOR INVESTIGATION OF THE COMPLAINT, RETENTION TUBES WERE INCUBATED AT 20 TO 25 DEGREES C (5 TUBES BATCH 2312543 AND 5 TUBES BATCH 3032615) AND 33 TO 37 DEGREES C (5 TUBES BATCH 2312543 AND 5 TUBES BATCH 3032615). AT 14 DAYS INCUBATION, NO GROWTH WAS OBSERVED IN 10/10 TUBES FROM BATCH 2312543 AND 10/10 TUBES FROM BATCH 3032615. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION IN BATCH 2312543 AND BATCH 3032615. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3032615. B5. IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, THERE WERE AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SHOWED AN INCREASE IN FALSE POSITIVE RESULTS. THE CUSTOMER REPORTED TWO OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. CUSTOMER NOTED AN INCREASE IN FALSE POSITIVE CASES IN THE MGIT INSTRUMENTS SINCE (B)(6)2023. THE FALSE POSITIVES WERE LOCATED IN DIFFERENT LOCATION (DIFFERENT INSTRUMENT, DIFFERENT DRAWERS AND SLOTS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SHOWED AN INCREASE IN FALSE POSITIVE RESULTS. THE CUSTOMER REPORTED TWO OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. CUSTOMER NOTED AN INCREASE IN FALSE POSITIVE CASES IN THE MGIT INSTRUMENTS SINCE JUNE 2023. THE FALSE POSITIVES WERE LOCATED IN DIFFERENT LOCATION (DIFFERENT INSTRUMENT, DIFFERENT DRAWERS AND SLOTS).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, THERE WERE AN UNKNOWN QUANTITY OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206634 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 3032615 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown