BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES

    MDR report key: 11195402 · Received January 19, 2021

    Report

    Report Number
    1119779-2021-00096
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 29, 2020
    Report Date
    April 28, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 REVIEW FOR BATCH 0002021 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 0002021 (100 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO CAP, TUBE, OR MEDIA DEFECTS IN 100/100 TUBES FROM VISUAL INSPECTION. FOR INVESTIGATION, A TOTAL OF TEN UNINOCULATED RETENTION TUBES WERE INCUBATED FOR SEVEN DAYS. FIVE TUBES WERE PLACED IN THE 33 TO 37 DEGREES C INCUBATOR AND FIVE TUBES WERE PLACED IN THE 20 TO 25 DEGREES C INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 10/10 INCUBATED RETENTION TUBES AT SEVEN DAYS INCUBATION, AND UNDER UV LIGHT THE INCUBATED TUBES DID NOT SHOW ANY INCREASED FLUORESCENCE TO INDICATE MICROBIAL GROWTH. THREE PHOTOS WERE RECEIVED IN LIEU OF RETURNS TO ASSIST WITH THE INVESTIGATION. THE FIRST PHOTO SHOWS A TUBE HELD BY THE CAP WITH BATCH INFORMATION FOR BATCH 0002021 FEATURED FOR VERIFICATION. THE OTHER TWO PHOTOS EACH SHOW A TUBE WITH WHAT APPEARS TO BE A WHITE SUBSTANCE FLOATING AT THE TOP OF THE MEDIA. THE WHITE MATERIAL COULD BE MICROBIAL GROWTH. THE COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL WHICH LED TO ERRONEOUS RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL" MGIT" MYCOBACTERIA GROWTH INDICATOR TUBES CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL WHICH LED TO ERRONEOUS RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90439 BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 0002021 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1