BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 11832143 · Received May 17, 2021

    Report

    Report Number
    1119779-2021-00837
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 16, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K014123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 245123 MGIT 960 SIRE SUPPLEMENT KIT BATCH 9352343 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 9317628, MGIT 960 STREPTOMYCIN BATCH 9277214, MGIT 960 ISONIAZID BATCH 9262751, MGIT 960 RIFAMPIN BATCH 9277218 AND MGIT 960 ETHAMBUTOL BATCH 9311821. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH 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. IT IS NOTED THAT KIT BATCH 9352343 EXPIRED ON 2021-03-19 AND THIS COMPLAINT WAS TAKEN ON APRIL 23, 2021. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. SOME OF THE KIT COMPONENTS WERE ALSO EXPIRED AT THE TIME THE COMPLAINT WAS TAKEN. THE EXPIRED COMPONENTS WERE STREPTOMYCIN BATCH 9277214 EXPIRED ON 2021-04-02, ISONIAZID EXPIRED ON 2021-03-19, AND RIFAMPIN EXPIRED ON 2021-04-02. THESE RETENTIONS WERE NOT AVAILABLE AT THE TIME THE COMPLAINT WAS TAKEN FOR INSPECTION. RETENTIONS FOR SIRE SUPPLEMENT BATCH 9317628 AND ETHAMBUTOL BATCH 0311821 WERE AVAILABLE FOR INSPECTION. SIRE SUPPLEMENT BATCH 9317628 10/10 VIALS WERE AVAILABLE WITH NO DEFECTS. ETHAMBUTOL BATCH 9311821 10/10 VIALS WERE AVAILABLE WITH NO DEFECTS. FOR FURTHER INVESTIGATION, TESTING ON SIRE SUPPLEMENT BATCH 931728 AND ETHAMBUTOL BATCH 0311821, FROM KIT BATCH 9352343, WAS PERFORMED AFTER EXPIRATION OF THE KIT BATCH AND THERE WERE NO PERFORMANCE/RESISTANCE ISSUES WITH TESTING. THE PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURE. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT RESULT OF ISONIAZID AND PZA HAD RESISTANT RESULTS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SIRE AND PZA TESTS WERE RELEASED BY MGIT WITH RESISTANT DRUGS, WHEN THEY WERE KNOWN TO BE SENSITIVE. WAS THIS FAILED QC? IF SO - PLEASE PROVIDE THE ATCC ORGANSIMS: IF PATIENTS - NEED TO CLARIFY IF THERE WAS ANY PATIENT IMPACT- NO IMPACT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT RESULT OF ISONIAZID AND PZA HAD RESISTANT RESULTS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SIRE AND PZA TESTS WERE RELEASED BY MGIT WITH RESISTANT DRUGS, WHEN THEY WERE KNOWN TO BE SENSITIVE. WAS THIS FAILED QC? IF SO - PLEASE PROVIDE THE ATCC ORGANSIMS: IF PATIENTS - NEED TO CLARIFY IF THERE WAS ANY PATIENT IMPACT- NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733087 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245123 9352343 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown