BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14599055 · Received June 3, 2022

    Report

    Report Number
    1119779-2022-00817
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    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. H3 OTHER TEXT : SEE H.10.

    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. 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,

    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. 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,".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601109 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 UNKNOWN 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown