BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15826321 · Received November 18, 2022

    Report

    Report Number
    1119779-2022-01403
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 22, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    10382902212635
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221263, 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. FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SIDE OF A SLEEVE OF PLATES WITH RED-COLORED MEDIA WITH CRACKED LIDS VISIBLE IN AT LEAST FIVE OF THE PLATES. TWO PHOTOS EACH SHOW THE SIDE OF A SLEEVE WITH ONE PLATE INSIDE OF THE SLEEVE WITH GROWTH IN THE MEDIA. THE LAST TWO PHOTOS EACH SHOW THE AGAR SURFACE OF A PLATE WITH GROWTH IN THE MEDIA. NO PLATE PRINTS FOR PRODUCT LABELS WERE VISIBLE IN THE PHOTOS FOR BATCH VERIFICATION. NO BATCH NUMBER OR RETURN SAMPLES WERE PROVIDED FOR INVESTIGATION. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221263 AND THERE ARE NO TRENDS FOR BROKEN PLATES OR CONTAMINATION IN ANY BATCH OVER THE LAST 12 MONTHS. TRENDING WAS PERFORMED ON THE APPROPRIATE QUALITY DATABASES. NO TRENDS FOR BROKEN PLATES WERE FOUND IN THE LAST 12 MONTHS. FOR CONTAMINATION, BD HAS IDENTIFIED A TREND FOR THIS PRODUCT. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. THIS COMPLAINT CANNOT BE CONFIRMED FOR A BROKEN PLATE DEFECT WITHOUT BATCH INFORMATION AND BATCH VERIFICATION IN THE PHOTOS. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION BASED ON THE IDENTIFIED TREND. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND BROKEN PLATES.

    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 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR IS REPORTING A COMPLAINT RECEIVED FROM THEIR CUSTOMER FOR ITEM 221263 (COLUMBIA BLOOD AGAR CS100). CUSTOMER NEEDS 2 CASES REPLACED. 1 CASE DUE TO CONTAMINATION. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ COLUMBIA AGAR WITH (B)(4) SHEEP BLOOD CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR IS REPORTING A COMPLAINT RECEIVED FROM THEIR CUSTOMER FOR ITEM 221263 (COLUMBIA BLOOD AGAR CS100). CUSTOMER NEEDS 2 CASES REPLACED. 1 CASE DUE TO CONTAMINATION. HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231569 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 221263 UNKNOWN 10382902212635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown