BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 16375195 · Received February 14, 2023

    Report

    Report Number
    1119779-2023-00133
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 27, 2023
    Report Date
    March 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: MGIT PANTA 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 BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH 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. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). PANTA BATCH NUMBER 2213216 WAS PROVIDED BY THE CUSTOMER. BATCH HISTORY REVIEW FOR PANTA BATCH 2213216 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS WERE AVAILABLE FOR INSPECTION FOR PANTA BATCH 2213216 (10 VIALS). NO EVIDENCE OF CONTAMINATION WAS OBSERVED IN 10/10 RETENTION VIALS. FOR FURTHER INVESTIGATION TWO PANTA VIALS WERE RECONSTITUTED WITH DISTILLED WATER. ONE PANTA RECONSTITUTED WITH DISTILLED WATER WAS INCUBATED AT 20-25-DEGREES CELSIUS AND ONE PANTA RECONSTITUTED WITH DISTILLED WATER WAS INCUBATED AT 33-37-DEGREES CELSIUS. FOR ADDITIONAL INVESTIGATION TWO PANTA VIALS WERE ALSO RECONSTITUTED WITH TWO SUPPLEMENT VIALS FROM BATCH 2213281. ONE PANTA RECONSTITUTED WITH SUPPLEMENT WAS INCUBATED AT 20-25-DEGREES CELSIUS AND ONE PANTA RECONSTITUTED WITH SUPPLEMENT WAS INCUBATED AT 33-37-DEGREES CELSIUS. AT THE END OF A FOURTEEN-DAY INCUBATION PERIOD THERE WAS NO MICROBIAL GROWTH OBSERVED IN 6/6 INCUBATED RETENTION VIALS. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: BOTH PHOTOS SHOW AN UNCRIMPED RECONSTITUTED PANTA VIAL FROM BATCH 2213216. THERE DOES APPEAR TO BE FUNGAL GROWTH IN THE VIAL. NO 245124-KIT BATCH NUMBER WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION AND NO RETURNS WERE RECEIVED FOR INVESTIGATION. HOWEVER, MANUFACTURING RECORDS FOR PANTA BATCH 2213216 WERE REVIEWED AND A PROBABLE KIT BATCH NUMBER WAS FOUND. REVIEW OF THE PROBABLE KIT BATCH NUMBER FOUND THE KIT PACKAGING PROCESS WAS SATISFACTORY AND THERE ARE NO COMPLAINTS TAKEN ON THE PROBABLE KIT BATCH.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: (B)(6). INITIAL REPORTER ADDRESS 1: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MGIT PANTA SUPPLEMENT WAS FOUND TO BE CONTAMINATED WITH WHAT APPEARS TO BE A FUNGAL GROWTH. IMAGES PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MGIT PANTA SUPPLEMENT WAS FOUND TO BE CONTAMINATED WITH WHAT APPEARS TO BE A FUNGAL GROWTH. IMAGES PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655045 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245124 2213216 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown