BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17865498 · Received October 3, 2023

    Report

    Report Number
    1119779-2023-01047
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 26, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 FOR BATCH 2335982 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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 BATCH 2335982 FOR PERFORMANCE. RETENTION SAMPLES FROM BATCH 2335982 WERE NOT AVAILABLE FOR TESTING. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. COMPLAINT TRENDING HAS NOT IDENTIFIED A TREND FOR PERFORMANCE DEFECTS ON THIS MATERIAL. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER INQUIRED WHY PRODUCT FLAGGED POS SO SLOWLY, AT 41 DAYS. 3 SAMPLES FOR SAME PATIENT, 2 SAMPLES WERE NEG AT 42 DAYS AND 1 WAS POS AT 41 DAYS. STAIN SHOWED AFB AND SUB WAS SLOW GROWING. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)?: PATIENT. CUSTOMER STATES INCREASED TIME TO DETECTION IN PATIENT SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: -CUSTOMER PROBLEM: CUSTOMER INQUIRED WHY PRODUCT FLAGGED POS SO SLOWLY, AT 41 DAYS. 3 SAMPLES FOR SAME PATIENT, 2 SAMPLES WERE NEG AT 42 DAYS AND 1 WAS POS AT 41 DAYS. STAIN SHOWED AFB AND SUB WAS SLOW GROWING. -WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT CUSTOMER STATES INCREASED TIME TO DETECTION IN PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741611 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 2335982 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown