BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14704974 · Received June 15, 2022

    Report

    Report Number
    1119779-2022-00877
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    November 15, 2021
    Report Date
    September 29, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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 1092611 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 PERFORMANCE COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH BESIDES THE CUSTOMER. RETENTION SAMPLES FROM BATCH 1092611 (100 TUBES) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES SHOWED NO DEFECTS IN 100/100 TUBES. THE RETENTIONS WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO ACTIONS ARE INDICATED AT THIS TIME AND BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    REPORT NUMBER 5 OF 6. IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. IT IS UNCLEAR WHAT TYPE OF CONFIRMATORY TEST WAS PERFORMED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A COUPLE OF VIALS GAVE A NEGATIVE RESULT FROM THE INSTRUMENT BUT THE SLIDE WAS THEN POSITIVE", "AS FOR THE PATIENT IMPACT I WAS TOLD THAT THEY HAVE STARTED THERAPY AND THE PATIENT IS STABLE."

    Description of Event or Problem · 0

    REPORT NUMBER 5 OF 6. IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. IT IS UNCLEAR WHAT TYPE OF CONFIRMATORY TEST WAS PERFORMED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A COUPLE OF VIALS GAVE A NEGATIVE RESULT FROM THE INSTRUMENT BUT THE SLIDE WAS THEN POSITIVE", "AS FOR THE PATIENT IMPACT I WAS TOLD THAT THEY HAVE STARTED THERAPY AND THE PATIENT IS STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120070 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 1092611 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown