BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18879275 · Received March 11, 2024

    Report

    Report Number
    1119779-2024-00196
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 16, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE LABELING PROCESS FOR MATERIAL 245122 INCLUDES LABEL RECONCILIATION, WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS (CARTONS/BOTTLES/TUBES/ETC.) USED IN THE BATCH HISTORY RECORD, REJECTED AND UNUSED. ANY DISCREPANCIES MUST BE WITHIN ALLOWABLE LIMITS SPECIFIED IN THE LABELING CONTROL PROCEDURE. THE LABEL ACCOUNTABILITY AND RECONCILIATION FOR BATCH 3152732 WERE WITHIN ALLOWABLE LIMITS. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER LABEL COMPLAINTS HAVE BEEN TAKEN ON BATCH 3152732. RETENTION SAMPLES (100) WERE AVAILABLE FOR INSPECTION. THERE WERE NO MISSING LABELS OBSERVED IN THE RETENTION SAMPLES. TWO PHOTOS WERE AVAILABLE FOR INSPECTION OF THIS COMPLAINT. ONE PHOTO SHOWED THREE TUBES WITHOUT LABELS. ONE PHOTO SHOWED A CARTON LABEL OF BATCH 3152732. NO RETURNS WERE RECEIVED TO ASSIST IN THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING LABELS DUE TO THE PHOTOS RECEIVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING DEFECTS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES WERE MISSING THE LABEL ON 5 TUBES. THERE WAS NO REPORT ON PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES WERE MISSING THE LABEL ON 5 TUBES. THERE WAS NO REPORT ON PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077206 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 3152732 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown