BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC MGIT 960 SIRE KIT

    MDR report key: 11649718 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00651
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 23, 2021
    Report Date
    October 6, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 0322955 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 0268967, MGIT 960 STREPTOMYCIN BATCH 0226683, MGIT 960 ISONIAZID BATCH 0226684, MGIT 960 RIFAMPIN BATCH 0226685, AND MGIT 960 ETHAMBUTOL BATCH 0226687. 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 FOR CONTAMINATION. 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). REVIEW OF THE BATCH HISTORY RECORDS FOR SIRE SUPPLEMENT BATCH 0268967, STREPTOMYCIN BATCH 0226683, ISONIAZID BATCH 0226684, RIFAMPIN BATCH 0226685 AND ETHAMBUTOL BATCH 0226687 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURE AND INSPECTION OF ANY COMPONENT BATCHES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE FOR EACH COMPONENT BATCH. RETENTION SAMPLES OF SIRE SUPPLEMENT BATCH 0268967 (10 VIALS), STREPTOMYCIN BATCH 0226683 (10 VIALS), ISONIAZID BATCH 0226684 (10 VIALS), RIFAMPIN BATCH 0226685 (10 VIALS) AND ETHAMBUTOL BATCH 0226687 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO CRIMP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN ANY OF THE RETENTION VIALS FROM VISUAL INSPECTION. FOR FURTHER INVESTIGATION FOUR ETHAMBUTOL¿S FROM BATCH 0226687 WERE TESTED. TWO ETHAMBUTOLS (BATCH 0226687) WERE RECONSTITUTED WITH THE SIRE SUPPLEMENT BATCH 0268967. ONE RECONSTITUTED ETHAMBUTOL WAS PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR; AND ONE RECONSTITUTED ETHAMBUTOL WAS PLACED INTO THE 33¿37-DEGREE CELSIUS INCUBATOR FOR ABOUT SEVEN DAYS. TWO NON-RECONSTITUTED ETHAMBUTOLS (BATCH 0226687) WERE ALSO INCUBATED. ONE NON-RECONSTITUTED ETHAMBUTOL WAS PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR; AND ONE NON-RECONSTITUTED ETHAMBUTOL WAS PLACED INTO THE 33¿37-DEGREE CELSIUS INCUBATOR FOR ABOUT SEVEN DAYS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN THE RECONSTITUTED OR NON-RECONSTITUTED ETHAMBUTOLS. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. RETENTION SAMPLE OBSERVATIONS AND TESTING DID NOT SHOW ANY SIGNS OF CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THE VIAL WAS DISCOVERED TO BE CONTAMINATED. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FENCH TO ENGLISH: ONE OF THE ETHAMBUTOL VIALS IS CONTAMINATED AND WE CANNOT PROCEED WITH THE RECONSTITUTION. NO IMPACT ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K003062. 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 USING BD BACTEC¿ MGIT¿ 960 SIRE KIT THE VIAL WAS DISCOVERED TO BE CONTAMINATED. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ONE OF THE ETHAMBUTOL VIALS IS CONTAMINATED AND WE CANNOT PROCEED WITH THE RECONSTITUTION. NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545892 BD BACTEC MGIT 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245123 0322955 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1