BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE BBL CHROMAGAR MRSA II 90MM 20 EA

    MDR report key: 12081404 · Received June 28, 2021

    Report

    Report Number
    9680577-2021-00021
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 31, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSO
    PMA / PMN Number
    K092767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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¿ CHROMAGAR® (B)(6) 100MM (20 EACH) CATALOG NUMBER 215228 WHICH HAS 510K NUMBER K092767.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT FOR BBL¿ CHROMAGAR¿ MRSA II, CATALOG NUMBER 257434, LOT NUMBER 1118437. EVENT DESCRIPTION: IT WAS REPORTED THAT THERE WAS NO GROWTH AFTER 48 HOURS OF INCUBATION. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. THERE WERE NO CONFIRMED COMPLAINTS RECEIVED DURING THAT PERIOD ON THIS PRODUCT. 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: PICTURES WERE PROVIDED SHOWING PLATES WITHOUT GROWTH. AN ANALYSIS OF GROWTH PROMOTION FOR THE MEDIA WAS PERFORMED ON RETENTION SAMPLES FOR BATCH 1118437. THE PERFORMANCE TESTS ON RETENTION SAMPLES OF THE ABOVE MENTIONED BATCH RESULTED IN EXCELLENT GROWTH OF THE FOLLOWING STRAINS: STAPH. AUREUS MRSA ATCC 33592, INCUBATION TIME 20-22 HOURS AT 35-37°C IN AEROB ATMOSPHERE. - STAPH. AUREUS MRSA ATCC 43300 INCUBATION TIME 20-22 HOURS AT 35-37°C IN AEROB ATMOSPHERE. - STAPH. EPIDERMIDIS MSSE ATCC 12228 INCUBATION TIME 42-48 HOURS AT 35-37°C IN AEROB ATMOSPHERE. NO DEVIATION COULD BE DETECTED IN THE RETENTION SAMPLES REGARDING PERFORMANCE OR FILLING ISSUES. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC PERFORMANCE TEST. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT AND BASED ON THE QC TEST RESULTS, THE COMPLAINT WAS NOT 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 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 PLATE BBL CHROMAGAR (B)(6) 90MM 20 EA ATYPICAL GROWTH 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: "NO GROWTH AFTER 48 HOURS OF INCUBATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE BBL CHROMAGAR MRSA II 90MM 20 EA ATYPICAL GROWTH 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: "NO GROWTH AFTER 48 HOURS OF INCUBATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977236 PLATE BBL CHROMAGAR MRSA II 90MM 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST JSO BECTON DICKINSON GMBH 1118437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown