BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL

    MDR report key: 12814390 · Received November 15, 2021

    Report

    Report Number
    9680577-2021-00078
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    November 6, 2021
    Report Date
    February 14, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT PLATES IN A BOX WERE FOUND TO BE CONTAMINATED. COMPLAINT HISTORY OF THE AFFECTED BATCH AND CATALOG NUMBER WAS REVIEWED FOR THE PAST 12 MONTHS. THREE SIMILAR COMPLAINTS WERE REGISTERED FOR BATCH 1223096. THEREFORE, A TREND WAS IDENTIFIED. NO DEVIATIONS FROM VALIDATED PROCESSES WERE REGISTERED. FURTHERMORE, THE AFFECTED BATCH MET ALL REQUIRED RELEASE SPECIFICATIONS AND NO DEVIATION WAS REGISTERED DURING QC RELEASE TESTING. THE MEDIUM ITSELF IS HEAT STERILIZED. HOWEVER, THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. SINCE A 100 % CONTROL FOR STERILITY IS NOT POSSIBLE A REPRESENTATIVE SAMPLING IS DONE BY THE QC DEPARTMENT. BATCH 1223096 COMPLIED TO OUR INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY. RETAIN SAMPLES WERE ANALYZED. NO DEVIATION WAS REGISTERED. PICTURE SAMPLES SHOW CONTAMINATION GROWING ON THE MEDIA. ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE GIVEN PRODUCT. SINCE A 100 % INSPECTION IS NOT POSSIBLE FOR ASEPTIC PRODUCTS, STERILITY TESTING CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. THEREFORE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED. HOWEVER, SINCE TREND WAS DETECTED, AN INTERDISCIPLINARY TEAM IS CURRENTLY DRIVING INVESTIGATIONS TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE ACTIONS TRIGGERED BY SAID TEAM. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT WAS CONFIRMED FOR CONTAMINATION.

    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¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL CATALOG NUMBER 221851 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ¿ONE BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL PLATE WAS¿ CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS ANOTHER PACKAGE OF SABOURAUD W CHLORAMPHENICOL CONTAMINATED BEFORE OPENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, ¿ONE BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL PLATE WAS¿ CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS ANOTHER PACKAGE OF SABOURAUD W CHLORAMPHENICOL CONTAMINATED BEFORE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712974 BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 1223096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown