BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL

    MDR report key: 15171813 · Received August 4, 2022

    Report

    Report Number
    9680577-2022-00091
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 18, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    UDI-DI
    00382902540915
    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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.FACILITY NAME: (B)(4).

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON RECENT COMPLAINT (B)(4) AGAINST SABOURAUD AGAR WITH CHLORAMPHENICOL, CATALOG NUMBER 254091, LOT NUMBER 2159395. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PLATES IN QUESTION ARE NOT SELECTIVE BUT ALSO ALLOW THE GROWTH OF GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA CREATING DIFFICULTIES IN THE INTERPRETATION OF COLONIES. 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 PERFORMANCE ON THE RETAIN SAMPLES FROM THIS COMPLAINED BATCH AND THE PERFORMANCE ISSUE COULD BE CONFIRMED,. A PICTURE SAMPLE DOCUMENTING THE REPORTED ISSUE WAS NOT PROVIDED. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. HOWEVER WHILE TESTING THE COMPLAINED BATCH, 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 WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL EXCESSIVE GROWTH OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE PLATES IN QUESTION ARE NOT SELECTIVE BUT ALSO ALLOW THE GROWTH OF GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA CREATING DIFFICULTIES IN THE INTERPRETATION OF COLONIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL EXCESSIVE GROWTH OCCURRED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE PLATES IN QUESTION ARE NOT SELECTIVE BUT ALSO ALLOW THE GROWTH OF GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA CREATING DIFFICULTIES IN THE INTERPRETATION OF COLONIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930201 BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 2159395 00382902540915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown