BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 12334300 · Received August 17, 2021

    Report

    Report Number
    9680577-2021-00046
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 5, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 1173789. IT WAS REPORTED THAT SOME PLATES IN 3 BOXES WOULD BE CONTAMINATED. THE COMPLAINT TRENDS WERE REVIEWED. THERE WERE NO SIMILAR CONFIRMED COMPLAINTS REPORTED DURING THAT PERIOD ON THIS LOT NUMBER. THEREFORE, A TREND COULD NOT BE IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATED PLATES. A VISUAL INSPECTION WAS PERFORMED ON THE RETENTION SAMPLE AND ONE STACK OF PLATES WERE INCUBATED. AS A RESULT OF THIS ANALYSIS NO CONTAMINATION WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 120 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD 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 "WE HAVE 3 BOXES OF 120 PLATES COL-S WITH 5%SB (REF: (B)(4), ALL SAME LOT NO. 1173789, EXP 27/09/2021) JUST OPENED AND SEVERAL AGARS IN EACH BOX SHOW GROWTH OF BACTERIA."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. 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 · 1

    IT WAS REPORTED THAT WHILE USING 120 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD 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 "WE HAVE 3 BOXES OF 120 PLATES COL-S WITH 5%SB (REF: (B)(4), ALL SAME LOT NO. 1173789, EXP 27/09/2021) JUST OPENED AND SEVERAL AGARS IN EACH BOX SHOW GROWTH OF BACTERIA. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229166 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1173789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown