BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 16051595 · Received December 27, 2022

    Report

    Report Number
    1119779-2022-01544
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 1, 2022
    Report Date
    May 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    PMA / PMN Number
    K021582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 251827 IS A REPACKAGING OF MATERIAL 245128 MGIT PZA KIT BY BD JAPAN. THE COMPONENT BATCHES OF A 251827 KIT BATCH ARE THE SAME COMPONENT BATCHES OF THE CORRESPONDING 245128 KIT BATCH. MATERIAL 245128 IS MANUFACTURED IN SPARKS (BALTIMORE), MD. THE FOLLOWING INFORMATION PERTAINS TO THE INVESTIGATION OF THE COMPONENT BATCHES OF KIT BATCH 2137763. KIT BATCH 2137763 IS COMPOSED OF MGIT PZA BATCH 2053011 AND MGIT 960 PZA SUPPLEMENT BATCH 2090224. 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. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PZA BATCH 2052011 AND MGIT PZA SUPPLEMENT BATCH 2090224 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING THE MANUFACTURE OR INSPECTION OF EITHER BATCH. THE FORMULATION PROCESSES WERE EACH WITHIN SPECIFICATION, AND QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE RECONSTITUTED IF APPROPRIATE FOR TESTING AND INCUBATED AT 25 C AND AT 35 C FOR 14 DAYS. ALL BIOBURDEN TESTING PERFORMED ON BOTH COMPONENT BATCHES BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND THERE ARE NO OTHER COMPLAINTS ON MGIT PZA BATCH 2052011 OR MGIT PZA SUPPLEMENT BATCH 2090224. RETENTION SAMPLES FROM PZA SUPPLEMENT BATCH 2090224 (10 VIALS) WERE AVAILABLE FOR INSPECTION. SAMPLES OF PZA BATCH 2053011 WERE NOT AVAILABLE FOR INSPECTION. FOR INVESTIGATION, TWO PZA SUPPLEMENT VIALS FROM BATCH 2090224 WERE INCUBATED AT 33 TO 37 DEGREES C (1 VIAL) AND 20 TO 25 DEGREES C (1 VIAL). NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 RETENTION VIALS AT 14 DAYS INCUBATION. SIX PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS THE LABEL FOR A 251827 KIT. THE SECOND PHOTO SHOWS PART OF CARTON LABEL WITH BATCH NUMBER 2137763 FEATURED. THE THIRD PHOTO SHOWS THE TOP OF AN OPENED CARTON WITH TWO UNCRIMPED, PARAFILMED WRAPPED AMBER VIALS. THE FOURTH PHOTO SHOWS TWO UNCRIMPED VIALS FROM BATCH 2090224. THE VAILS HAVE PARAFILM AROUND THE STOPPERS. THE FIFTH PHOTO ALSO SHOWS TWO UNCRIMPED AMBER VIALS. THE MEDIA INSIDE OF THE VIALS IS DIFFICULT TO OBSERVE. THE SIXTH PHOTO SHOWS A PZA SUPPLEMENT VIAL WITH MEDIA THAT IS TURBID WITH POSSIBLE FUNGAL GROWTH. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A SMALL SHIPPING BOX WAS RECEIVED. INSIDE THE SHIPPING BOX WAS A REPACKAGED PZA SUPPLEMENT BOX WITH A JAPAN MATERIAL NUMBER 251827. INSIDE THE KIT CARTON WERE TWO PZA SUPPLEMENT VIALS FROM BATCH 2090224. THE VIALS WERE UNCRIMPED AND HAD PARAFILM AROUND THE STOPPERS. ONE VIAL APPEARED TO HAVE BEEN USED BUT THERE WAS NO EVIDENCE OF CONTAMINATION OR TURBID MEDIA IN THE VIAL. FOR INVESTIGATION THIS VIAL WAS INCUBATED AT 33 TO 37 DEGREES C. AT 14 DAYS INCUBATION, NO MICROBIAL GROWTH WAS OBSERVED. THE OTHER RETURNED VIAL DID NOT APPEAR TO BE USED DUE TO THE FILL VOLUME BUT THERE WAS FUNGAL CONTAMINATION IN THE VIAL. THE VIAL SUBMITTED TO ID LAB AND A VERTICILLIUM SPECIES WAS IDENTIFIED. CONTAMINATION IN THE RETURN SAMPLE FROM BATCH 2090224 IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 PZA KIT HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE PZA SUPPLEMENT OUT OF 3 WAS FOUND TO BE CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 PZA KIT HAD CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE PZA SUPPLEMENT OUT OF 3 WAS FOUND TO BE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449524 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 2137763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown