BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 13922115 · Received March 26, 2022

    Report

    Report Number
    1119779-2022-00469
    Event Type
    Malfunction
    Date Received
    March 26, 2022
    Date of Event
    February 25, 2022
    Report Date
    July 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. PMA/510(K)#: K003062 / K014123.

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION: MGIT 960 SIRE SUPPLEMENT KIT BATCH 1327635 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 1287906, MGIT 960 STREPTOMYCIN BATCH 1273575, MGIT 960 ISONIAZID BATCH 1264963, MGIT 960 RIFAMPIN BATCH 1264964 AND MGIT 960 ETHAMBUTOL BATCH 1258661. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH 1327635 WAS SATISFACTORY AND NO QUALITY 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). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION; ISONIAZID BATCH 1264963 (8 VIALS), STREPTOMYCIN BATCH 1273575 (10 VIALS), RIFAMPIN BATCH 1264964 (10 VIALS), ETHAMBUTOL BATCH 1258661 (10 VIALS) AND SUPPLEMENT BATCH 1287906 (8 VIALS). ALL RETENTION SAMPLE VIALS WERE IN GOOD CONDITION. FOR INVESTIGATION RETENTION SAMPLE TESTING WAS PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL RETENTION SAMPLE TESTING WERE SATISFACTORY PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS COMPLAINT CANNOT BE CONFIRMED. NOTES: RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY S4, PER [BALTRMLMBACTECMGITAPH ], REV 03, ID 2.7.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SIRE KIT HAS BEEN FOUND EXPERIENCING REAGENT ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: SINCE WE RECEIVED THE NEW BATCH OF KIT 245123 (SIRE ANTIBIOTIC), WE HAVE RUN 7 SUSCEPTIBILITY TESTS. OF THE 7, 6 CAME OUT INVALID DUE TO LOW GROWTH IN THE GC TUBE. WE HAVE NOT CARRIED OUT QC WITH CONTROL ORGANISMS. SO I CAN'T GIVE YOU ANY RESULTS. I UNDERSTAND THAT FROM YOUR SIDE, IF I DON'T HAVE A TEST ON A CONTROL STRAIN, YOU CAN'T DO MUCH FOR ME. FROM TIME TO TIME WE HAVE HAD GCS FROM OUR SIRES COME OUT INVALID (3-4 PER YEAR OUT OF AN AVERAGE OF 35 ATBS). BUT WE HAVE NEVER HAD 6 INVALID GCS IN A ROW AFTER THE INTRODUCTION OF A NEW BATCH. IN THE MEANTIME, WE HAVE 3 ATBS THAT HAD ALREADY BEEN LAUNCHED AND THAT CAME OUT CORRECTLY. AFTER VARIOUS EMAIL EXCHANGES WITH CUSTOMER, WE HAVE MODIFIED THE PERFORMANCE OF THE ANTIBIOGRAMS (PREPARATION OF THE INOCULUM, HOMOGENISATION OF THE STRAIN,) WE HOPE NOT TO HAVE ANY MORE PROBLEMS NOW.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SIRE KIT HAS BEEN FOUND EXPERIENCING REAGENT ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: SINCE WE RECEIVED THE NEW BATCH OF KIT 245123 (SIRE ANTIBIOTIC), WE HAVE RUN 7 SUSCEPTIBILITY TESTS. OF THE 7, 6 CAME OUT INVALID DUE TO LOW GROWTH IN THE GC TUBE. WE HAVE NOT CARRIED OUT QC WITH CONTROL ORGANISMS. SO I CAN'T GIVE YOU ANY RESULTS. I UNDERSTAND THAT FROM YOUR SIDE, IF I DON'T HAVE A TEST ON A CONTROL STRAIN, YOU CAN'T DO MUCH FOR ME. FROM TIME TO TIME WE HAVE HAD GCS FROM OUR SIRES COME OUT INVALID (3-4 PER YEAR OUT OF AN AVERAGE OF 35 ATBS). BUT WE HAVE NEVER HAD 6 INVALID GCS IN A ROW AFTER THE INTRODUCTION OF A NEW BATCH. IN THE MEANTIME, WE HAVE 3 ATBS THAT HAD ALREADY BEEN LAUNCHED AND THAT CAME OUT CORRECTLY. AFTER VARIOUS EMAIL EXCHANGES WITH CUSTOMER, WE HAVE MODIFIED THE PERFORMANCE OF THE ANTIBIOGRAMS (PREPARATION OF THE INOCULUM, HOMOGENISATION OF THE STRAIN,...). WE HOPE NOT TO HAVE ANY MORE PROBLEMS NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880839 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245123 1327635 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Unknown