BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    MDR report key: 12485647 · Received September 16, 2021

    Report

    Report Number
    1119779-2021-01541
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 3, 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. INITIAL REPORTER PHONE NUMBER: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0142002, MEDICAL DEVICE EXPIRATION DATE: 2021-11-17, DEVICE MANUFACTURE DATE: 2020-05-21, MEDICAL DEVICE LOT #: 9094593, MEDICAL DEVICE EXPIRATION DATE: 2020-09-26, DEVICE MANUFACTURE DATE: 2019-04-04. 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. BATCHES 0142002 AND 9094593 (COMPLAINT # (B)(4)) THE BATCH HISTORY RECORD REVIEW FOR BATCHES 0142002 AND 9094593 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. CHECKS FOR FILL VOLUME WERE COMPLETE AND WITHIN SPECIFICATIONS PER PROCEDURES AND 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. BATCH 0142002: THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0142002 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO LOW FILL VOLUME WAS OBSERVED IN 100/100 TUBES. THE FILL VOLUME WAS MEASURED USING A FILL VOLUME MEASURING TOOL. BATCH 9094593: THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 9094593 (100 TUBES) WERE NOT AVAILABLE FOR INSPECTION. IT IS NOTED THAT BATCH 9094991 EXPIRED ON 2020-10-03 AND THE COMPLAINT WAS TAKEN FROM THE CUSTOMER ON (B)(6) 2020. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF BOTH COMPLAINTS. THE FIRST PHOTO SHOWS THREE TUBES, WHERE THE TUBE ON THE LEFT DOES APPEAR TO HAVE A LARGE MASS OF GROWTH IN THE TUBE. THE MIDDLE TUBE APPEARS TO BE TURBID TOWARD THE SENSOR. THE TUBE ON THE RIGHT DOES NOT APPEAR TURBID BUT THE FILL VOLUME DOES APPEAR LOWER THAN EXPECTED. FURTHER INVESTIGATION OF THIS PHOTO SHOWS THE LOW FILL VOLUME TUBE IS FROM BATCH 0142002 AND THE MIDDLE, TURBID, TUBE IS FROM BATCH 9094593. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. EIGHT TUBES WERE RECEIVED IN A (B)(4) CARDBOARD SHIPPING ENVELOP. ALL TUBES WERE RECEIVED IN GOOD CONDITION. ONE TUBE EACH WAS FROM BATCH 0142002 AND 9094593 WERE RECEIVED. ONE TUBE FROM BATCH 9094593 SHOWS EVIDENCE OF CONTAMINATION. THE COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION FOR BATCH 9094593. THE ONE TUBE FROM BATCH 0142002 WAS MEASURED USING A MEASURING DEVICE AND WAS OUT OF THE ACCEPTABLE FILL VOLUME RANGE. THE COMPLAINT CAN BE CONFIRMED FOR LOW FILL VOLUME FOR BATCH 0142002. DUE TO THE LOW DEFECT LEVEL, THERE ARE NO ACTIONS PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR LOW FILL VOLUME AND CONTAMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 200 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML A PHYSICAL DEFECT AND FUNGAL CONTAMINATION WERE OBSERVED BY THE LABORATORY PERSONNEL. 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: "IS LESS VOLUME AND FUNGAL GROWTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380373 BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 SEE H.10. 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1