BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MUELLER HINTON II AGAR

    MDR report key: 14025394 · Received April 6, 2022

    Report

    Report Number
    1119779-2022-00519
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 4, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    UDI-DI
    10382902218002
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221800, PLATE MUELLER HINTON II AGAR 24 EA, BATCH NUMBER 2012767 AND COMPLAINT NUMBER (B)(4) FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221800, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD FOR BATCH 2012767 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2012767. RETENTION SAMPLES FROM BATCH 2012767 WERE NOT AVAILABLE FOR INSPECTION. TWENTY-FOUR PLATES FROM BATCH 2012767 AS SIX SLEEVES (5 UNOPENED, 1 OPENED) IN 24PACK CARTON SHIPPED IN A BOX WITH BUBBLE WRAP AND ICE PACKS. IN THE OPENED SLEEVE, 1/4 PLATES HAD SURFACE FUNGAL GROWTH (TIME STAMP 1227). THE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND THE GROWTH WAS IDENTIFIED AS TRICHOPHYTON SPECIES. THE FIVE UNOPENED SLEEVES WERE INCUBATED PRIOR TO INSPECTION AT 20 TO 25 DEGREES C (2 SLEEVES) AND 33 TO 37 DEGREES C (3 SLEEVES). AT 5 DAYS INCUBATION, 0/20 PLATES INCUBATED HAD MICROBIAL GROWTH (TIME STAMPS 1215, 1227 AND 1228). FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SIDE OF A SLEEVE WITH MICROBIAL GROWTH IN ONE PLATE VISIBLE. THE OTHER FOUR PHOTOS EACH SHOW DIFFERENT VIEWS OF A PLATE FROM BATCH 2012767 (TIME STAMP 1227) WITH FUNGAL GROWTH ON THE AGAR. THIS COMPLAINT HAS BEEN CONFIRMED. BASED ON THE LOW DEFECT RATE FOR THIS BATCH (1 REPORTED PLATE), NO ACTIONS ARE INDICATED AT THIS TIME. THIS PRODUCT DOES NOT HAVE A STERILE CLAIM. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MUELLER HINTON II AGAR PLATE WAS FOUND CONTAMINATED WITH MICROBIAL GROWTH BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATES , PACKAGE ARRIVED WITH RIGHT TEMPERATURE AND PACKAGING." "THE MICROBIAL GROWTH WAS OBSERVED DURING THE VISUAL INSPECTION WHEN THE MATERIAL ARRIVED AT THE LABORATORY. THE STORAGE OF THE MATERIAL WAS AS PER RECEIVED (ICE PACKS)." "WE RECEIVED 6 CASES (144 PLATES), ONLY ONE PLATE SHOWED MICROBIAL GROWTH, THIS DOES NOT ALLOW US TO RECEIVE THE MATERIAL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MUELLER HINTON II AGAR PLATE WAS FOUND CONTAMINATED WITH MICROBIAL GROWTH BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATES , PACKAGE ARRIVED WITH RIGHT TEMPERATURE AND PACKAGING." "THE MICROBIAL GROWTH WAS OBSERVED DURING THE VISUAL INSPECTION WHEN THE MATERIAL ARRIVED AT THE LABORATORY. THE STORAGE OF THE MATERIAL WAS AS PER RECEIVED (ICE PACKS)." "WE RECEIVED 6 CASES (144 PLATES), ONLY ONE PLATE SHOWED MICROBIAL GROWTH, THIS DOES NOT ALLOW US TO RECEIVE THE MATERIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444600 BD BBL¿ MUELLER HINTON II AGAR CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 221800 2012767 10382902218002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown