BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14517843 · Received May 26, 2022

    Report

    Report Number
    1119779-2022-00766
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 27, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6 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 1230008 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1230008 (100 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO MEDIA DEFECTS IN 100/100 TUBES FROM VISUAL INSPECTION. THE RETENTION SAMPLES WERE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURES FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY AND THE NEGATIVE CONTROL REMAINED NEGATIVE THROUGHOUT TESTING. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS MICROGRAPH RESULTS ON THE COMPUTER NO PRODUCT INFORMATION CAN BE SEEN FROM THE PHOTO. THE SECOND PHOTO ALSO SHOWS MICROGRAPH RESULTS ON THE COMPUTER. NO PRODUCT INFORMATION CAN BE SEEN IN THE PHOTO. WITHOUT PRODUCT INFORMATION A PHOTO ALONE CANNOT CONFIRM A COMPLAINT. A PHOTO MUST PROVIDE THE PRODUCT, THE PRODUCT DEFECT, AND IMPORTANT PRODUCT INFORMATION SUCH AS BATCH/LOT NUMBER. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY S4, PER BALTRMLMBACTECMGITAPH, REV 03, ID 1.11. QN: (B)(4). DW: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML FALSE NEGATIVE RESULTS WERE 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: WE HAVE A POSITIVE MGIT CULTURE TUBE WHICH CAME OFF THE MGIT AS NEGATIVE AT 6 WEEKS. UPON ZN MICROSCOPY WE NOTE A VERY SCANTY BACTERIAL LOAD. WE WERE EXPECTING THE LOAD TO BE MUCH GREATER, AS IT WAS CULTURED IN DUPLICATE AND THE OTHER TUBE CAME OFF POSITIVE AFTER ONLY 3 WEEKS WITH A HIGH BACTERIAL LOAD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML FALSE NEGATIVE RESULTS WERE 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: WE HAVE A POSITIVE MGIT CULTURE TUBE WHICH CAME OFF THE MGIT AS NEGATIVE AT 6 WEEKS. UPON ZN MICROSCOPY WE NOTE A VERY SCANTY BACTERIAL LOAD. WE WERE EXPECTING THE LOAD TO BE MUCH GREATER, AS IT WAS CULTURED IN DUPLICATE AND THE OTHER TUBE CAME OFF POSITIVE AFTER ONLY 3 WEEKS WITH A HIGH BACTERIAL LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785687 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 1230008 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown