BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 19997009 · Received August 15, 2024

    Report

    Report Number
    1119779-2024-00610
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 19, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G.4. PMA/510(K)#: K014123 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 MGIT 960 SIRE SUPPLEMENT KIT BATCH 3171140 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 3095249, MGIT 960 STREPTOMYCIN BATCH 3103736, MGIT 960 ISONIAZID BATCH 3103738, MGIT 960 RIFAMPIN BATCH 3103739 AND MGIT 960 ETHAMBUTOL BATCH 3103740. THE BATCH HISTORY RECORD REVIEWS FOR THE KIT AND EACH OF ITS COMPONENTS WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT 960 SIRE SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). THE BATCH HISTORY RECORD FOR ISONIAZID BATCH 3103738 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILTERING AND FILLING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM BATCH 3103738 WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTED FOR ANTIBIOTIC GROWTH AND SUSCEPTIBILITY WAS SATISFACTORY AND IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS.

    Description of Event or Problem · 0

    REPORT 2 OF 4 IT WAS REPORTED AFTER USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, A FALSE RESISTANT INH RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING AT TULSA (TUBERCULOSIS LABORATORY SURVEILLANCE NETWORK) AND A SENSITIVE/SUSCEPTIBLE INH RESULT WAS OBTAINED. A DELAY FOR INH REPORTING OCCURRED; HOWEVER, NO FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 4. IT WAS REPORTED AFTER USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, A FALSE RESISTANT INH RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING AT TULSA (TUBERCULOSIS LABORATORY SURVEILLANCE NETWORK) AND A SENSITIVE/SUSCEPTIBLE INH RESULT WAS OBTAINED. A DELAY FOR INH REPORTING OCCURRED; HOWEVER, NO FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008268 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 3171140 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown