BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16512874 · Received March 9, 2023

    Report

    Report Number
    1119779-2023-00253
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 2251097 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. 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 2251097 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 100 RETENTION SAMPLES. TEN UNINOCULATED RETENTION TUBES WERE PLACED INTO INCUBATION TO TEST FOR CONTAMINATION. FIVE TUBES WERE PLACED INTO THE 20 TO 25 DEGREES CELSIUS INCUBATOR AND FIVE TUBES WERE PLACED INTO THE 33-TO-37-DEGREE CELSIUS INCUBATOR. AT SEVEN DAYS INCUBATION, THERE WERE NO TRACES OF MICROBIAL GROWTH IN THE 10/10 INCUBATED RETENTION TUBES, AND UNDER UV LIGHT THERE WAS NO INCREASED FLUORESCE GLOW. ONE PHOTO AND ONE VIDEO WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS FIFTEEN TUBE FORM BATCH 2251097. THERE DOES APPEAR TO BE GROWTH FIVE TUBES. THE SECOND PHOTO SHOWS NINE TUBES. THERE DOES APPEAR TO BE POSSIBLE GROWTH IN THREE TUBES. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTOS RECEIVED. HOWEVER, IT CANNOT BE CONCLUDED IT IS BIOLOGICAL OR NON-BIOLOGICAL IN NATURE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML BLACK COLORATION WAS SEEN ON THE BOTTOM OF TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE MGIT 7ML TUBES GAVE A POSITIVE ALARM ON THE MGIT 960 DEVICE, BLACK COLORATION WAS SEEN ON THE BOTTOM OF THE REMOVED TUBES.THIS HAS HAPPENED IN MANY PATIENTS. THE DECONTAMINATION STEPS WERE QUESTIONED. WAS AN ACID-FAST SMEAR PERFORMED ON THE SAMPLES (AS STATED IN THE IFU)? // YES, IT WAS PERFORMED. WHAT WAS THE RESULT OF THIS TEST? // THERE WERE EXAMPLES WHERE BACILLI APPEARED AND DID NOT APPEAR. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? // YES, IT WAS REPORTED. THE SAMPLES WERE PREPARED FOR RE-STUDY IN OUR MGIT SYSTEM. THE STUDY OF SOLID CULTURE (LJ) IS ONGOING. IF SO, WAS THERE ANY NEGATIVE IMPACT ON THE PATIENT? // NO, IT DIDN'T HAVE A NEGATIVE EFFECT. IT ONLY CAUSED THE DURATION OF PATIENT OUTCOMES TO BE EXTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML BLACK COLORATION WAS SEEN ON THE BOTTOM OF TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE MGIT 7ML TUBES GAVE A POSITIVE ALARM ON THE MGIT 960 DEVICE, BLACK COLORATION WAS SEEN ON THE BOTTOM OF THE REMOVED TUBES. THIS HAS HAPPENED IN MANY PATIENTS. THE DECONTAMINATION STEPS WERE QUESTIONED. WAS AN ACID-FAST SMEAR PERFORMED ON THE SAMPLES (AS STATED IN THE IFU)?: YES, IT WAS PERFORMED. WHAT WAS THE RESULT OF THIS TEST?: THERE WERE EXAMPLES WHERE BACILLI APPEARED AND DID NOT APPEAR. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN?: YES, IT WAS REPORTED. THE SAMPLES WERE PREPARED FOR RE-STUDY IN OUR MGIT SYSTEM. THE STUDY OF SOLID CULTURE (LJ) IS ONGOING. IF SO, WAS THERE ANY NEGATIVE IMPACT ON THE PATIENT?: NO, IT DIDN'T HAVE A NEGATIVE EFFECT. IT ONLY CAUSED THE DURATION OF PATIENT OUTCOMES TO BE EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659290 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 2251097 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown