BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ POTATO DEXTROSE AGAR DEEP FILL

    MDR report key: 11967783 · Received June 9, 2021

    Report

    Report Number
    1119779-2021-00978
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 296272, MEDIA IS FORMULATED USING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN ISO CERTIFIED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED 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 A 1069149 WAS SATISFACTORY PER INTERNAL PROCEDURES. 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: 1069149. RETENTION SAMPLES FROM BATCH: 1069149 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO SHOWS THE SIDE OF A SLEEVE OF LIGHT TAN-CREAM PLATES WITH WHAT COULD BE LIGHT BROWN GROWTH IN THE SLEEVE. NO PRODUCT LABELS WERE VISIBLE IN THE PHOTO FOR BATCH VERIFICATION. WITHOUT BATCH VERIFICATION, THE PHOTO CANNOT CONFIRM THE COMPLAINT. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    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 WHILE USING BD BBL¿ POTATO DEXTROSE AGAR DEEP FILL MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING MOLD CONTAMINATION IN MEDIA ITEM: 296272, LOT: 1069149 - PLATE POTATO DEXTROSE DEEP FILL. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ POTATO DEXTROSE AGAR DEEP FILL MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " *CUSTOMER PROBLEM: CUSTOMER REPORTING MOLD CONTAMINATION IN MEDIA ITEM 296272 LOT 1069149 - PLATE POTATO DEXTROSE DEEP FILL. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863829 BD BBL¿ POTATO DEXTROSE AGAR DEEP FILL CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 1069149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown