BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MACCONKEY II AGAR 90MM

    MDR report key: 12392725 · Received August 31, 2021

    Report

    Report Number
    9680577-2021-00054
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 3, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    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

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST MACCONKEY II AGAR, CATALOG NUMBER 254078, LOT NUMBER 1173866. EVENT DESCRIPTION: IT WAS REPORTED THAT 14 PLATES WERE FOUND TO BE CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE RECORDED FOR THE RESPECTIVE BATCH. HOWEVER, SINCE THIS PRODUCT IS FILLED ASEPTICALLY WITH AN AQL FOR STERILITY OF 1.5 RARE CONTAMINATION EVENTS ARE TO BE EXPECTED. THEREFORE A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATION FROM THE VALIDATED PROCESSES AND PARAMETERS WERE REGISTERED. SAMPLE ANALYSIS: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. PICTURE SAMPLE WAS PROVIDED SHOWING CONTAMINATED PLATES. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) 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 4.9%. BASED UPON OUR CONTINUOUS MONITORING, WE DERIVE A CONTAMINATION RATE THAT FALLS 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 CONTAMINATED PLATES. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION AND AND PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. WE WOULD SUGGEST TO 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). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 14 PLATES MACCONKEY II AGAR 90MM 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 "14 PLATES ARE CONTAMINATED.

    Additional Manufacturer Narrative · 1

    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¿ MACCONKEY II AGAR CATALOG NUMBER 221172 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 14 PLATES MACCONKEY II AGAR 90MM 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 "14 PLATES ARE CONTAMINATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296097 PLATE MACCONKEY II AGAR 90MM CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 1173866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown