BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 17774518 · Received September 19, 2023

    Report

    Report Number
    1119779-2023-01012
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 29, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K014123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5 PMA / 510(K): K003062 K014123. H.3. 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

    H.6 INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 2201728 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 2152424, MGIT 960 STREPTOMYCIN BATCH 2132042, MGIT 960 ISONIAZID BATCH 2132043, MGIT 960 RIFAMPIN BATCH 2132044 AND MGIT 960 ETHAMBUTOL BATCH 2132046. 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 MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION: SIRE SUPPLEMENT BATCH 2152424 (8 VIALS), MGIT 960 STREPTOMYCIN BATCH 2132042 (10 VIALS), MGIT 960 ISONIAZID BATCH 2132043 (10 VIALS), MGIT 960 RIFAMPIN BATCH 2132044 (10 VIALS) AND MGIT 960 ETHAMBUTOL BATCH 2132046 (10 VIALS). ALL 48/48 VIALS WERE IN GOOD CONDITION AND FILLED WITH MEDIA. FOR INVESTIGATION OF THIS COMPLAINT ALL STREPTOMYCIN BATCH 2132042 (10/10 VIALS) AND ETHAMBUTOL BATCH 2132046 (10/10 VIALS); ALL 20 VIALS MAINTAINED WERE FILLED WITH LYOPHILIZED MEDIA. FOR FURTHER INVESTIGATION FOUR SIRE SUPPLEMENT VIALS FROM BATCH 2152424 WERE INCUBATED. TWO SUPPLEMENT VIAL CRIMP CAPS WERE REMOVED. ONE UNCRIMPED AND ONE CRIMPED SEALED SUPPLEMENT VIAL WERE PLACED INTO THE 20-25-DEGREE CELSIUS INCUBATOR. ONE UNCRIMPED AND ONE CRIMP SEALED SUPPLEMENT VIAL WERE PLACED INTO THE 33-37-DEGREES CELSIUS INCUBATOR. AT FOURTEEN DAYS OF INCUBATION NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. TWO PHOTOS AND ONE VIDEO WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS AN UNCRIMPED SIRE SUPPLEMENT VIAL FROM BATCH 2152424 (THE STOPPER IS STILL IN THE VIAL). NO CONTAMINATION CAN BE SEEN IN THIS PHOTO. THE SECOND PHOTO SHOWS A BOX LABEL FOR MATERIAL 245123, BATCH 2201728, EXPIRATION 2023-11-10. THE VIDEO SHOWS AN UNCRIMPED SIRE SUPPLEMENT VIAL FROM BATCH 2152424 (THE STOPPER IS STILL IN THE VIAL). THERE APPEARS TO BE A FOREIGN MATERIAL/POSSIBLE CONTAMINATION INSIDE OF THE VIAL. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT HAS BEEN CONFIRMED BY THE PHOTOS AND VIDEO RECEIVED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CUSTOMER UNBOX VIALS OF SIZE KIT, THEY SAW COLOR OF LYOPHILIZED DRUG INSIDE HAVE WEIRD AND AFTER THEY RECONSTITUTE VIAL, THEY SAW HAVE STRANGE OBJECT IN THE SOLUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CUSTOMER UNBOX VIALS OF SIZE KIT, THEY SAW COLOR OF LYOPHILIZED DRUG INSIDE HAVE WEIRD AND AFTER THEY RECONSTITUTE VIAL, THEY SAW HAVE STRANGE OBJECT IN THE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518948 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 2201728 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown