BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 22935113 · Received September 2, 2025

    Report

    Report Number
    1119779-2025-04756
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    October 2, 2023
    Report Date
    July 31, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451280
    PMA / PMN Number
    K021582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FAX #: (B)(6). INVESTIGATION SUMMARY: 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). A TREND FOR PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR 245128 MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE PERFORMANCE ISSUE. HOWEVER, INVESTIGATIONS HAVE NOT FOUND A DEFECT IN THIS KIT BATCH 2161925. FOR THE PERFORMANCE DEFECT INVESTIGATIONS, RETENTION SAMPLES TESTED PER THE STANDARD PERFORMANCE PROCEDURE, WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING), WERE SATISFACTORY AND HAVE NOT REPLICATED REPORTED FALSE RESISTANCE DEFECTS. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. A PHOTO WAS PROVIDED SHOWING THE KIT BATCH NUMBER. THE BATCH HISTORY RECORD WAS SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING FOR THE CAPA. RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WAS A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260879 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 2161925 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown