BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPLATE MACCON/COL CNA IMPR 5% SB120

    MDR report key: 12253435 · Received July 30, 2021

    Report

    Report Number
    9680577-2021-00037
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    June 30, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT 3171507 AGAINST BD¿ MACCONKEY II AGAR / COLUMBIA CNA AGAR IMPROVED II WITH 5% SHEEP BLOOD (BIPLATE), CATALOG NUMBER 257584, LOT NUMBER 1104466. EVENT DESCRIPTION: IT WAS REPORTED THAT CONTAMINATION WAS DETECTED ON SOME PLATES. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED. THERE WERE NO SIMILAR COMPLAINTS RECEIVED ON THIS BATCH NUMBER. THEREFORE, A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. PICTURES WERE PROVIDED SHOWING THE REPORTED CONTAMINATION. EVALUATION RESULTS: 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. PLEASE NOTE THAT THE VALID STANDARD FOR THESE PRODUCTS IS DIN EN 12322 "IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY". ACCORDING TO THIS STANDARD THE CONTAMINATION RATE FOR EACH PRODUCT LOT MUST NOT EXCEED (B)(6). FOR OUR CONTINUOUS MONITORING, WE DERIVE A CONTAMINATION RATIO FOR BELOW THIS SPECIFIED VALUE. ACCORDING TO OUR HIGH QUALITY STANDARD, 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. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE PROVIDED REPORT AND PICTURE SAMPLE, THE COMPLAINT WAS CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. WE WOULD SUGGEST THAT YOU SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER <1117> ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIPLATE MACCON/COL CNA IMPR 5% SB120 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: "CONTAMINATED PLATES."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 W/5% SHEEP BLOOD // MACCONKEY II AGAR CATALOG NUMBER 221600 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIPLATE MACCON/COL CNA IMPR 5% SB120 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: "CONTAMINATED PLATES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152317 BIPLATE MACCON/COL CNA IMPR 5% SB120 CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1104466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown