BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20

    MDR report key: 15124931 · Received July 28, 2022

    Report

    Report Number
    9680577-2022-00086
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 5, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY EVENT DESCRIPTION: IT WAS REPORTED THAT SEVERAL PLATES WOULD NOT BE SELECTIVE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED AND FOR THIS PRODUCT, SEVERAL COMPLAINTS WERE REPORTED FOR A PERFORMANCE ISSUE. THEREFORE, A TREND WAS IDENTIFIED, AND FURTHER INVESTIGATION WAS PERFORMED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY HAS BEEN REVIEWED. IT WAS IDENTIFIED THAT THE CHLORAMPHENICOL CONTAINING IN THIS PRODUCT WAS PROBABLY AFFECTED AND FURTHER FINISHED PRODUCTS WERE IDENTIFIED. SAMPLE ANALYSIS: A PERFORMANCE TEST HAS BEEN CONDUCTED ON THE RETAIN SAMPLES OF THE COMPLAINED BATCH 2150314. THE RESULTS SHOWED NOT DEVIATION; HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED. RETURN SAMPLES WERE NOT PROVIDED; HOWEVER, A PICTURE WAS SHARED SHOWING GROWTH ON PLATES. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ALSO THE RETEST PERFORMED ON THE RETAIN SAMPLES OF THE COMPLAINED BATCH 2150314 DID NOT REVEAL ANY DEVIATION TO THE REQUIREMENT. HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED FOR EXCESSIVE GROWTH. BD HAS IDENTIFIED AN OUTSIDE SUPPLIER ISSUE WITH THIS PLATE¿S IMPREGNATED ANTIBIOTIC, CHLORAMPHENICOL, WHICH RESULTS IN A REDUCTION IN THE ANTIBACTERIAL ACTIVITY OF THE CHLORAMPHENICOL OVER THE SHELF LIFE OF THE AGAR. AS A RESULT A PRODUCT RECALL HAS BEEN INITIATED FOR THE AFFECTED LOTS IN THE AFFECTED REGIONS. BASED ON THE ABOVE MENTIONED EVALUATION, THIS COMPLAINT WAS CONFIRMED. BD REGRETS THE INCONVENIENCES YOU HAVE BEEN EXPERIENCING DUE TO THIS ISSUE AND BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 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: "HEREWITH TO REPORT THE ABUNDANT GROWTH OF GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA ON VARIOUS SOILS IN SABOURAUD . "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 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: "HEREWITH TO REPORT THE ABUNDANT GROWTH OF GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA ON VARIOUS SOILS IN SABOURAUD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924526 BD PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 2150314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown