BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16478991 · Received March 3, 2023

    Report

    Report Number
    1119779-2023-00215
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 26, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED OR UPDATED: H6. MEDICAL DEVICE PROBLEM CODE: A090803. 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. BATCH 2181610. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2181610 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2181610 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA, OR TUBE DEFECTS WERE OBSERVED IN 100 /100 RETENTION SAMPLES. RETENTIONS SAMPLES WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER QC PROCEDURES FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. BATCH 2111438. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2111438 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2111438 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA, OR TUBE DEFECTS WERE OBSERVED IN 100 /100 RETENTION SAMPLES. RETENTIONS SAMPLES WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER QC PROCEDURES FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. NO PHOTOS OR RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR EITHER BATCH BASED ON RETENTION SAMPLE TESTING. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE ISSUES. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #:2181610. MEDICAL DEVICE EXPIRATION DATE:2023-12-24. DEVICE MANUFACTURE DATE: 2022-06-30. 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 THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL MGIT TUBES THAT FLAG AS NEGATIVE AFTER 6 WEEKS ARE INSPECTED VISUALLY FOR ¿CRUMBS¿ TO ENSURE NOTHING IS MISSED. WE HAVE RECENTLY SEEN AN INCREASE IN TUBES THAT FLAG NEGATIVE AT 6 WEEKS, HOWEVER HAVE VERY OBVIOUS ¿CRUMBS¿ GROWING IN THE TUBE. IN ALL INSTANCES (6 THAT WERE PROCESSED WITHIN A TWO WEEK PERIOD) WE HAVE ISOLATED AFB (INCLUDING TB) WHICH IS CONCERNING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL MGIT TUBES THAT FLAG AS NEGATIVE AFTER 6 WEEKS ARE INSPECTED VISUALLY FOR ¿CRUMBS¿ TO ENSURE NOTHING IS MISSED. WE HAVE RECENTLY SEEN AN INCREASE IN TUBES THAT FLAG NEGATIVE AT 6 WEEKS, HOWEVER HAVE VERY OBVIOUS ¿CRUMBS¿ GROWING IN THE TUBE. IN ALL INSTANCES (6 THAT WERE PROCESSED WITHIN A TWO WEEK PERIOD) WE HAVE ISOLATED AFB (INCLUDING TB) WHICH IS CONCERNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870845 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 2111438 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown