BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES

    MDR report key: 22167441 · Received June 9, 2025

    Report

    Report Number
    1119779-2025-00550
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 12, 2025
    Report Date
    September 8, 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
    JA
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. D9. RETURNED TO MANUFACTURER ON: 22-JUL-2025. H3. DEVICE EVAL BY MANUFACTURER? YES. INVESTIGATION SUMMARY: MATERIAL 245122 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD FOR BATCH 4221365 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE QC RELEASE TESTING, INSPECTION FOR PHYSICAL ATTRIBUTES WAS CONDUCTED ON SAMPLES REPRESENTATIVE OF THE BATCH TO ENSURE CONFORMANCE TO PRODUCT SPECIFICATIONS. PHYSICAL ATTRIBUTE TESTING WAS SATISFACTORY FOR THIS BATCH. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. PHOTOS AND RETURNS WERE AVAILABLE FOR INVESTIGATION. THREE PHOTOS WERE RECEIVED. ONE OF THE PHOTOS SHOWS SEVERAL TUBES FROM BATCH 4221365 LAYING ON A COUNTER. THE SECOND AND THIRD PHOTOS SHOW A CLOSE UP OF WHITE SEDIMENT AT THE BOTTOM OF A MGIT 7ML TUBE. SEVEN TUBES FROM BATCH 4221365 WERE RETURNED IN A BOX WITH BUBBLE WRAP OVER ZIP LOCK BAG WITH OTHER COMPLAINTS. WHITE SEDIMENT WAS OBSERVED IN THE BOTTOM OF THE TUBES. TUBES WERE THEN DIRECT INCUBATED AT 20 TO 25 DEGREES C AND 33 TO 37 DEGREES C AND NO GROWTH WAS OBSERVED AFTER INCUBATION. THE SEDIMENT WAS GRAM STAINED AND GRAM-POSITIVE COCCI WERE OBSERVED. TO RULE OUT VIABILITY, THE SEDIMENT WAS SUBCULTURED INTO NON-SELECTIVE LIQUID MEDIA (TSB) AND INCUBATED. NO GROWTH WAS OBSERVED. THE WHITE SEDIMENT OBSERVED IN THE RETURN SAMPLES WAS NON-VIABLE ORGANISMS. RETENTION SAMPLES WERE NOT REQUIRED TO BE ANALYZED AS THE DEFECT WAS CONFIRMED VIA THE RETURN AND PHOTOS. THIS COMPLAINT IS CONFIRMED FOR NON-VIABLES. THIS COMPLAINT CANNOT BE CONFIRMED FOR VIABLE CONTAMINATION. NO COMPLAINT TREND FOR CONTAMINATION (VIABLE OR NON-VIABLE) HAS BEEN IDENTIFIED FOR THIS PRODUCT. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. A COMPLAINT INVESTIGATION WAS INITIATED FOLLOWING CUSTOMER REPORTS OF A VISIBLE ¿WHITE PELLET¿ ON THE MGIT SENSOR SURFACE, WHICH WAS IDENTIFIED AS A BUILDUP OF NON-VIABLE BACTERIA. CONCERNS FROM CUSTOMER FEEDBACK PROMPTED A REVIEW OF THE OVERALL MANUFACTURING PROCESS FOR THIS PRODUCT. IT WAS DETERMINED THAT INADEQUATE CLEANING OF EQUIPMENT DOWNSTREAM OF THE IN-PROCESS FILTER CAUSED AN INCREASE IN BACTERIAL GROWTH WITHIN THE MEDIA PRIOR TO AUTOCLAVING. ONCE THE ORGANISMS WERE KILLED THROUGH THE AUTOCLAVING CYCLE, THEIR REMNANTS SETTLED DOWN TO THE BOTTOM OF THE TUBE. THE CLEANING PROTOCOLS WERE ENHANCED, AND THE INTRODUCTION OF A SONICATION PROCESS WAS INTRODUCED TO ELIMINATE MEDIA RESIDUE AND BIOFILMS. THESE ACTIONS HAVE BEEN APPLIED TO BATCHES MANUFACTURED AFTER JUNE 11, 2025 (CAT NO. 245122, BATCH 5142790).

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) TUBE WAS OBSERVED TO HAVE CONTAMINATION LOCATED AT THE BOTTOM OF THE TUBE. THE USER DESCRIBED THE CONTAMINANT AS "SOMETHING THAT LOOKS LIKE BACTERIA." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, ONE (1) TUBE WAS OBSERVED TO HAVE CONTAMINATION LOCATED AT THE BOTTOM OF THE TUBE. THE USER DESCRIBED THE CONTAMINANT AS "SOMETHING THAT LOOKS LIKE BACTERIA." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634069 BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4221365 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown