BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14323936 · Received May 7, 2022

    Report

    Report Number
    1119779-2022-00670
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 7, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451228
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL (SINGAPORE) PTE LTD (NUH).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

    H6: 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 1034908 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 1034908 FOR PERFORMANCE. RETENTION SAMPLES FROM BATCH 1034908 WERE AVAILABLE FOR INSPECTION. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROTOCOL FOR MATERIAL 245122. THIS INCLUDES GROWTH SUPPORT TESTING OF THE MYCOBACTERIUM ORGANISMS LISTED IN THE CERTIFICATE OF ANALYSIS (COA). IN THE RETENTION SAMPLES TESTED, GROWTH OF ALL ORGANISMS TESTED WAS DETECTED BY THE INSTRUMENT WITHIN THE SPECIFIED TIME OF EACH ORGANISM AS EXPECTED. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO FEATURES A CARTON LABEL FROM BATCH 1034908 FOR BATCH VERIFICATION. THE OTHER THREE PHOTOS EACH SHOW A SCREEN FROM BD EPICENTER WITH A NEGATIVE RESULT OR DATA PLOT FROM A TEST STARTED ON FEBRUARY 18, 2022 AND ENDED ON 04/01/2021. NO CONCLUSIONS CONCERNING PERFORMANCE OF THE PRODUCT CAN BE MADE FROM THE PHOTOS OR DATA SHOW IN THE PHOTOS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. TESTING OF RETENTION SAMPLES WAS SATISFACTORY FOR GROWTH SUPPORT OF MYCOBACTERIUM ORGANISMS. THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. POST-TESTING OBSERVATION OF THE TUBE FOUND THAT THE TUBE CONTAINED BACTERIAL GROWTH AND SHOULD HAVE PRODUCED POSITIVE RESULTS. 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: FLOC WAS SEEN AT THE BOTTOM OF THE TUBE WHEN REMOVED FROM THE INSTRUMENT AT DAY 42 (END OF PROTOCOL). ADDITIONAL TESTING REVEALED THE FLOC TO BE MTB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. POST-TESTING OBSERVATION OF THE TUBE FOUND THAT THE TUBE CONTAINED BACTERIAL GROWTH AND SHOULD HAVE PRODUCED POSITIVE RESULTS. 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: "FLOC WAS SEEN AT THE BOTTOM OF THE TUBE WHEN REMOVED FROM THE INSTRUMENT AT DAY 42 (END OF PROTOCOL). ADDITIONAL TESTING REVEALED THE FLOC TO BE MTB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250346 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 1034908 00382902451228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown