BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 16482892 · Received March 3, 2023

    Report

    Report Number
    1025402-2023-00002
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 20, 2023
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: MGIT 960 SUPPLEMENT KIT BATCH 2161305 IS COMPOSED OF MGIT PANTA BATCH 2161188 AND 960 GROWTH SUPPLEMENT BATCH 2161242. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 2161305 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. 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). THE COMPONENTS OF KIT BATCH 2161305 WERE REVIEWED AND ALL BATCH HISTORY RECORDS WERE SATISFACTORY AT TIME OF RELEASE PER INTERNAL PROCEDURES. PERFORMANCE OF EACH KIT COMPONENT WAS SATISFACTORY PER PROCEDURES. RETENTION SAMPLES WERE INSPECTED FOR SUPPLEMENT BATCH 2161242 (5 VIALS) AND PANTA BATCH 2161188 (10 VIALS) AND NO MEDIA DEFECTS WERE OBSERVED IN ANY OF THESE RETENTION SAMPLES INSPECTED. FOR FURTHER INVESTIGATION, TWO PANTA VIALS WERE RECONSTITUTED WITH TWO SUPPLEMENT VIALS. ONE RECONSTITUTED PANTA AND REMAINING SUPPLEMENT WAS INCUBATED AT 20-25-DEGREES CELSIUS, AND ONE RECONSTITUTED PANTA AND REMAINING SUPPLEMENT WAS INCUBATED AT 33-37-DEGREES CELSIUS. AT THE END OF A FOURTEEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 4/4 INCUBATED RETENTION VIALS. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: ¿ THE PHOTO SHOWS A PARTIAL RECONSTITUTED PANTA VIAL FROM BATCH 2161188 (THE CAP CANNOT BE SEEN). THERE DOES APPEAR TO BE A BEAN-LIKE FUNGAL CONTAMINATE IN THE VIAL. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE EVIDENCE PROVIDED BY THE PHOTO RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT AFTER DISSOLUTION PREP A BROAD BEAN WAS SEEN AND SUSPECTED THAT IT WAS A MOLD BLOB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER DISSOLUTION, IT WAS FOUND THAT THERE WAS A FOREIGN BODY THE SIZE OF BROAD BEAN IN THE SOLUTION, WHICH DID NOT DISSOLVE FOR A LONG TIME. THE CUSTOMER SUSPECTED THAT IT WAS A MOLD BLOB AND REFUSED TO USE THE BOX FOR EXPERIMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT AFTER DISSOLUTION PREP A BROAD BEAN WAS SEEN AND SUSPECTED THAT IT WAS A MOLD BLOB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER DISSOLUTION, IT WAS FOUND THAT THERE WAS A FOREIGN BODY THE SIZE OF BROAD BEAN IN THE SOLUTION, WHICH DID NOT DISSOLVE FOR A LONG TIME. THE CUSTOMER SUSPECTED THAT IT WAS A MOLD BLOB AND REFUSED TO USE THE BOX FOR EXPERIMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453234 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 2161305 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown