BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL

    MDR report key: 20354743 · Received October 2, 2024

    Report

    Report Number
    9680577-2024-00030
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 2, 2024
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    UDI-DI
    30382902540411
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4170384; D4. MEDICAL DEVICE EXPIRATION DATE: 19-SEP-2024; D4. UNIQUE IDENTIFIER (UDI) #: (B)(4); H4. DEVICE MANUFACTURE DATE: 18-JUN-2024. INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATION ON MULTIPLE PLATES, WITH ASPERGILLUS VERSICOLOR. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS AND NO SIMILAR COMPLAINTS WERE REPORTED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE DETECTED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETURNED SAMPLE ANALYSIS: RETAIN SAMPLES OF BOTH LOT NUMBERS WERE REVIEWED AND NO CONTAMINATION COULD BE OBSERVED. NEITHER RETURN NOR PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. EVALUATION SUMMARY: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. HOWEVER, STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY, A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT BASED ON A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED BY 100%; ALTHOUGH THE CONTAMINATION RATE REMAINS BELOW THE ACCEPTANCE LEVEL. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON THE ABOVE-MENTIONED EVALUATION AND THE ABSENCE OF SAMPLES OR PICTURES, THE COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. BD REGRETS THE INCONVENIENCES YOU HAVE EXPERIENCED AND WILL CONTINUE TO MONITOR SIMILAR INCOMING COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 4162838. B5. IT WAS REPORTED WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL THAT MULTIPLE PLATES WERE CONTAMINATED WITH ASPERGILLUS VERSICOLOR. GROWTH APPEARED IN AREAS WHERE SAMPLE WAS NOT INOCULATED SO IT WAS AN OBVIOUS CONTAMINANT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20034 BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 4162838 30382902540411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown