BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD AGAR W CHLORAMPHENICOL, PLATE

    MDR report key: 12779580 · Received November 9, 2021

    Report

    Report Number
    9680577-2021-00075
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 12, 2021
    Report Date
    December 17, 2021
    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 FOR THIS FIELD. 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 W CHLORAMPHENICOL & GENTAMICIN DEEP FILL CATALOG NUMBER 296359 WITH 510K NUMBER EXEMPT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT (B)(4) AGAINST BDTM SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL CATALOG NUMBER 254041, LOT NUMBER 1223098 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: TEN PLATES OF MEDIUM LOT 1223098 SHOWED MICROBIAL CONTAMINATION. THE CONTAMINATION WAS IDENTIFIED AS A MOLD. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS. NO SIMILAR COMPLAINTS WERE REGISTERED FOR THE AFFECTED LOT NUMBER. THE NUMBER OF REGISTERED CONTAMINATION COMPLAINTS FOR CATALOG NUMBER 254041 DID NOT REACH AN ACTION LIMIT. CATALOG NUMBER 254041 IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE, INSTEAD OF A STERILITY CLAIM AN INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) APPLIES FOR THESE PRODUCTS. THIS CLAIM IS NOT VIOLATED, THEREFORE A TREND CANNOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATION FROM THE VALIDATED PROCESSES AND PARAMETERS WERE REGISTERED. STERILIZATION RECORD REVIEW: CATALOG NUMBER 254041 IS FILLED UNDER ASEPTIC CONDITIONS. HOWEVER, THE MEDIUM ITSELF IS HEAT STERILIZED PRIOR TO THE FILLING PROCESS. REVIEW OF THE BHR SHOWED NO DEVIATION FROM THE VALIDATED STERILIZATION PROCESS. IN ADDITION, STERILITY TESTING IN THE QC DEPARTMENT FOR LOT 1223098 WAS SATISFACTORY. SAMPLE ANALYSIS: RETURN SAMPLES NOT PROVIDED BY THE CUSTOMER. PROVIDED PICTURE SAMPLES SHOW A STACK OF PLATES WHEREAS THE PLATES ITSELF ARE CONTAMINATED AT THE EDGE. THE PACKAGING SLEEVE SEEMS TO BE INTACT. RETAIN SAMPLES ANALYZED DURING INVESTIGATION SHOWED NO SIGN OF CONTAMINATION. EVALUATION RESULTS: SINCE THE BHR SHOWED NO DEVIATIONS WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN THE MANUFACTURING PROCESSES. THE AFFECTED LOT COMPLIED WITH ALL SPECIFICATIONS DURING RELEASE TESTING. NO FURTHER COMPLAINTS ARE REGISTERED FOR THE AFFECTED BATCH. HOWEVER, BASED ON THE PICTURE PROVIDED BY THE CUSTOMER THE COMPLAINT CAN BE CONFIRMED FOR MICROBIAL CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. INVESTIGATION CONCLUSION: ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE 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, TO IMPROVE THE SITUATION BD IS ALWAYS TRYING TO IMPROVE THE PROCESSES. DEDICATED TEAMS ARE DRIVING INVESTIGATIONS AND IMPROVEMENT PROCESSES TO FURTHER REDUCE THE RATE OF SUBLIMINAL CONTAMINATION FROM HAPPENING. WE ARE SORRY FOR THE INCONVENIENCE. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA THAT DOES NOT MEET THE APPEARANCE AND PERFORMANCE 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 ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ SABOURAUD AGAR W CHLORAMPHENICOL, PLATE 10 PLATES WERE DISCOVERED TO HAVE MOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: I CONFIRM THAT WE HAVE RECEIVED AGAIN THE PLATES CONTAMINATED WITH MOLD,

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ SABOURAUD AGAR W CHLORAMPHENICOL, PLATE 10 PLATES WERE DISCOVERED TO HAVE MOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: I CONFIRM THAT WE HAVE RECEIVED AGAIN THE PLATES CONTAMINATED WITH MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681986 BD BBL¿ SABOURAUD AGAR W CHLORAMPHENICOL, PLATE CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1223098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown