BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    MDR report key: 11301391 · Received February 9, 2021

    Report

    Report Number
    1119779-2021-00276
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS PRODUCT 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 REVIEW FOR BATCH 0231573 WAS SATISFACTORY AND A QUALITY NOTIFICATION WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND TORQUEING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. 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. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0231573 (100 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO CAP, TUBE, OR MEDIA DEFECTS IN 100/100 TUBES FROM VISUAL INSPECTION. TWO PHOTOS WERE RECEIVED IN LIEU OF RETURNS TO ASSIST WITH THE INVESTIGATION. THE FIRST PHOTO SHOWS A TUBE FROM BATCH 0231473. THE SECOND PHOTO SHOWS WHAT APPEARS TO BE A WHITE CIRCULAR PARTICLE. FOR INVESTIGATION, A TOTAL OF TEN UNINOCULATED RETENTION TUBES WEN INTO INCUBATION. FIVE TUBES WERE PLACED IN THE 33 TO 37 DEGREES CELSIUS INCUBATOR AND FIVE TUBES WERE PLACED IN THE 20 TO 25 DEGREES CELSIUS INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 10/10 INCUBATED RETENTION TUBES AT THE END OF THE INCUBATION PERIOD, AND UNDER UV LIGHT THE INCUBATED TUBES DID NOT SHOW ANY INCREASED FLUORESCENCE TO INDICATE MICROBIAL GROWTH. NO MICROBIAL GROWTH WAS OBSERVED IN THE RETENTION SAMPLES. THE COMPLAINT CAN BE CONFIRMED FROM THE PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML GROWTH WITHOUT SAMPLE INOCULATION WAS DISCOVERED IN TUBE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML GROWTH WITHOUT SAMPLE INOCULATION WAS DISCOVERED IN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198320 BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 0231573 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1