BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 11832047 · Received May 17, 2021

    Report

    Report Number
    1119779-2021-00836
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 16, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451280
    PMA / PMN Number
    K021582
    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: MGIT 960 PZA KIT BATCH 9296612 IS COMPOSED OF MGIT PZA BATCH 9213411 AND MGIT 960 PZA SUPPLEMENT BATCH 9213405. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 PZA KIT BATCH 9296612 WAS SATISFACTORY. BACTEC MGIT 960 PZA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC MGIT 960 PZA 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 SOP. TWO BACTEC MGIT 960 PZA VIALS ARE THEN MANUALLY PACKAGED WITH SIX BACTEC MGIT 960 PZA SUPPLEMENT VIALS TO COMPLETE A BACTEC MGIT 960 PZA KIT (MATERIAL 245128). NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR PERFORMANCE BUT WERE ALSO NOT CONFIRMED. BATCH HISTORY RECORD REVIEWS FOR MGIT PZA BATCH 9213411 AND MGIT 960 PZA SUPPLEMENT BATCH 9213405 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE FORMULATION PROCESSES WERE EACH WITHIN SPECIFICATION, AND QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE FOR BOTH BATCHES. RETENTION SAMPLES FROM PZA BATCH 9213411 WERE NOT AVAILABLE FOR INSPECTION. RETENTION SAMPLES FROM PZA SUPPLEMENT BATCH 9213405 WERE AVAILABLE FOR INSPECTION. THERE WERE NO CRIMP, VIAL OR MEDIA DEFECTS OBSERVED IN 10/10 RETENTION VIALS FROM SUPPLEMENT BATCH 9213405. NO RETENTIONS WERE AVAILABLE FOR PZA DRUG BATCH 9213411. FOR FURTHER TESTING, RETENTION SAMPLES FROM SUPPLEMENT BATCH 9213405 WERE PERFORMANCE TESTED PER THE STANDARD PERFORMANCE PROTOCOL FOR PZA SUPPLEMENT WHICH INCLUDES MYCOBACTERIUM TUBERCULOSIS H37RV ATCC 27294. ALL ORGANISMS TESTED HAD THE EXPECTED SUSCEPTIBILITY RESULT, ATCC 27294 WAS SENSITIVE, WHEN USING THIS BATCH OF PZA SUPPLEMENT AND ALL GROWTH CONTROLS WERE SATISFACTORY. NO PERFORMANCE DEFECTS WERE OBSERVED WITH TESTING OF PZA SUPPLEMENT BATCH 9213405.. IT IS NOTED THAT KIT BATCH 9296612 EXPIRED ON 2021-01-30 AND THIS COMPLAINT WAS TAKEN ON APRIL 23, 2021. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ MGIT¿ 960 PZA KIT THE 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 "ORGANISMS": 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 WHILE TESTING WITH BD BACTEC¿ MGIT¿ 960 PZA KIT THE 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 ORGANISMS: IF PATIENTS - NEED TO CLARIFY IF THERE WAS ANY PATIENT IMPACT- NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728471 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245128 9296612 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown