BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL

    MDR report key: 12919967 · Received December 2, 2021

    Report

    Report Number
    1119779-2021-01908
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 5, 2021
    Report Date
    January 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO, CATALOG NUMBER 221174, PLATE MIDDLEBROOK 7H10 DEEP FILL 20 EA, BATCH NUMBER 1165124 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221174, 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 1165124 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 1165124. RETENTION SAMPLES FROM BATCH 1165124 WERE NOT AVAILABLE FOR INSPECTION.

    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¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL BACTERIAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION WITH 221174 PLATE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL BACTERIAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION WITH 221174 PLATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818549 BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1165124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown