BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 12824728 · Received November 16, 2021

    Report

    Report Number
    9680577-2021-00080
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    November 9, 2021
    Report Date
    March 12, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: COMPLAINT HISTORY WAS REVIEWED AND A TREND WAS IDENTIFIED FOR THIS PRODUCT. A BATCH HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. PICTURES WERE NOT PROVIDED. RETENTION SAMPLES COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT KNOWN. BASED ON THE INTERNAL INVESTIGATION, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. SINCE A TREND WAS IDENTIFIED, A THOROUGH INVESTIGATION IS CURRENTLY UNDERWAY. THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED. IN THIS CASE, A TREND WAS IDENTIFIED. CURRENTLY SEVERAL CROSS-FUNCTIONAL TEAMS ARE CONDUCTING EXTENSIVE INVESTIGATION TO REDUCE THE OCCURRENCE FOR SUCH SUBLIMINAL CONTAMINATIONS. PLEASE BE AWARE THAT SUCH INVESTIGATION WILL TAKE ITS TIME. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. WE WOULD SUGGEST THAT YOU SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221263 WHICH IS A CLASS 1, PREAMENDMENT DEVICE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ONE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE WAS CONTAMINATED WITH MOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH THE LAST DELIVERY OF THE COS COLUMBIA AGAR PLATES (ITEM NO. 254071), A LARGE NUMBER OF THE PLATES WERE CONTAMINATED WITH MOLD, WHICH UNFORTUNATELY WE COULD NOT USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ONE BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD PLATE WAS CONTAMINATED WITH MOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH THE LAST DELIVERY OF THE COS COLUMBIA AGAR PLATES (ITEM NO. 254071), A LARGE NUMBER OF THE PLATES WERE CONTAMINATED WITH MOLD, WHICH UNFORTUNATELY WE COULD NOT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717538 BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown