BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 20162889 · Received September 6, 2024

    Report

    Report Number
    1119779-2024-00663
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 8, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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: 4051124 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH: 4004145, MGIT 960 STREPTOMYCIN BATCH: 4011792, MGIT 960 ISONIAZID BATCH: 4011790, MGIT 960 RIFAMPIN BATCH: 3335245, AND MGIT 960 ETHAMBUTOL BATCH: 4026719. THE BATCH HISTORY RECORD REVIEWS FOR THE KIT AND EACH OF ITS COMPONENTS WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH OR ANY OF THE COMPONENTS. 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). RETENTION SAMPLES FROM THE COMPONENTS FROM KIT BATCH: 4051124 WERE AVAILABLE FOR INSPECTION. RETENTION SAMPLES WERE PERFORMANCE TESTED FOR ANTIBIOTIC SUSCEPTIBILITY PER THE BD STANDARD PERFORMANCE PROTOCOL AS DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE) FOR THIS PRODUCT (AVAILABLE ON BD.COM/E-LABELING). ALL ORGANISMS TESTED FOR ANTIBIOTIC SUSCEPTIBILITY AS LISTED IN THE CERTIFICATE OF ANALYSIS, HAD EXPECTED RESULTS FROM THE INSTRUMENT WITHIN 4-13 DAYS AS LISTED IN THE IFU. GROWTH CONTROLS FOR THIS TEST ALSO WERE SATISFACTORY. ANTIBIOTIC SUSCEPTIBILITY TESTING WAS SATISFACTORY WITH DETECTIBLE GROWTH CONTROLS AND EXPECTED SUSCEPTIBILITY RESULTS FOR THE ORGANISMS AGAINST THE DRUGS TESTED. THERE WERE NO PHOTOS OR RETURNED SAMPLES FROM BATCH: 4051124 RECEIVED FOR INVESTIGATION. RETENTION SAMPLE TESTING OF THE BATCH IN QUESTION WAS SATISFACTORY. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF PATIENT SAMPLE SETS HAD INSUFFICIENT GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, AN UNSPECIFIED NUMBER OF PATIENT SAMPLE SETS HAD INSUFFICIENT GROWTH. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301512 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 4051124 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown