BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 21985393 · Received May 8, 2025

    Report

    Report Number
    1119779-2025-00367
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 15, 2025
    Report Date
    August 5, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902518273
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD SITE IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS FUKUSHIMA, JP IS A REPACKAGING SITE FOR THE JAPANESE MARKET ONLY. E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. D4. MEDICAL DEVICE LOT #: 4193239 WAS REPORTED; HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. UPDATED TO UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MATERIAL NUMBER 251827, KIT BATCH NUMBER UNKNOWN, COMPONENT BATCH NUMBER 4193239 FOR FOREIGN MATERIAL. THIS PRODUCT IS REPACKAGED IN JAPAN FROM MATERIAL NUMBER 245128 TO 251827. THE INVESTIGATION DETAILS REGARDING PRODUCTION AND QUALITY INSPECTION ARE BASED ON MANUFACTURING RECORDS FOR 245128. MGIT 960 PZA KIT IS COMPOSED OF MGIT PZA SOLUTION AND MGIT 960 PZA SUPPLEMENT. 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 BATCH NUMBER FOR KIT BATCH WAS AVAILABLE FOR REVIEW. HOWEVER, COMPONENT BATCH NUMBER WAS CONFIRMED VIA THE PHOTOS PROVIDED FOR INVESTIGATION. BATCH HISTORY RECORD REVIEWS FOR MGIT 960 PZA SUPPLEMENT BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING, TORQUING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN FOR COMPONENT BATCH 4193239. TWO PHOTOS WERE RECEIVED TO ASSIST WITH INVESTIGATION. ONE PHOTO SHOW 1 VIAL OF PZA SUPPLEMENT DISPLAYING BATCH NUMBER 4193239 AND EXPIRATION DATE 2026-01-14. A SECOND PHOTO SHOWS THE VIAL FROM A DIFFERENT ANGLE; THIS PHOTO SHOWS A FOREIGN OBJECT, WHICH APPEARS TO BE COTTON LIKE IN TEXTURE AND IRREGULAR IN SHAPE. THIS COMPLAINT CAN BE CONFIRMED FOR PRESENCE OF FOREIGN MATERIAL. 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 PRESENCE OF FOREIGN MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF A BD BACTEC¿ MGIT¿ 960 PZA KIT, ONE (1) VIAL WAS OBSERVED TO BE CONTAMINATED WITH A "FLOATING OBJECT." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF A BD BACTEC¿ MGIT¿ 960 PZA KIT, ONE (1) VIAL WAS OBSERVED TO BE CONTAMINATED WITH A "FLOATING OBJECT." THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035933 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382902518273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown