BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 14077432 · Received April 11, 2022

    Report

    Report Number
    9680577-2022-00057
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 18, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    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

    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 CNA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221353 WITH 510K NUMBER PREAMENDMENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THAT 35 PLATES WOULD HAVE SHOW CONTAMINATION. THE COMPLAINT TRENDS WERE REVIEWED AND SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT NUMBER. THEREFORE, A MRB (MATERIAL REVIEW BOARD) WAS PERFORMED AND THE RESULTS WERE DOCUMENTED WITHIN A CID (CORRECTIVE AND PREVENTIVE ACTION INITIATION DETERMINATION). THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. PICTURES WERE PROVIDED SHOWING THE REPORTED CONTAMINATION. THE RETENTION SAMPLES WERE REVIEWED AND ONE PLATE WITH CONTAMINATION WAS DETECTED. AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. AS SEVERAL COMPLAINTS WERE REPORTED FOR THIS PRODUCT LOT NUMBER REGARDING CONTAMINATION, FURTHER EVALUATION WILL BE CONDUCTED VIA CID. AS A ROOT CAUSE IT COULD BE IDENTIFIED THAT THE BLOOD POOL WHICH WAS USED DURING A TIMELY ISOLATED PRODUCTION FRAME WAS CONTAMINATED. THE CONTAMINANT WHICH WAS ALSO IDENTIFIED ON ONE PLATE IN THE RETAIN SAMPLES, IS EASY DETECTABLE AS IT GROWS BEFORE INCUBATION. BASED UPON OUR INVESTIGATION THE COMPLAINT WAS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323390 BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 2004161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown