BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 16272558 · Received January 31, 2023

    Report

    Report Number
    9680577-2023-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    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

    H.6 INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT 6892292 AGAINST COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254007, LOT NUMBER UNKNOWN EVENT DESCRIPTION: THE CUSTOMER REPORTED A POORLY SELECTIVE MEDIA, COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED FOR A PERIOD OF 12 MONTHS AND SIMILAR ISSUE WERE REPORTED FOR THIS CATALOG NUMBER. HOWEVER NO TREND WAS IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR COULD NOT BE REVIEWED SINCE THE RIGHT BATCH NUMBER WAS NOT COMMUNICATED. SAMPLE ANALYSIS: RETAIN SAMPLES WERE NOT REVIEWED SINCE THE RIGHT BATCH NUMBER COULD NOT BE COMMUNICATED. RETURN SAMPLES WERE NOT PROVIDED HOWEVER PICTURE ILLUSTRATING A PLATE WITH BACTERIAL GROWTH WAS PROVIDED. EVALUATION RESULTS: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. SINCE THE RIGHT BATCH NUMBER WAS NOT COMMUNICATED NO FURTHER INVESTIGATION COULD BE DETECTED. INVESTIGATION CONCLUSION: BASED ON THE ABOVE MENTIONED EVALUATION, THE COMPLAINT CANNOT BE CONFIRMED. HOWEVER BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE.

    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. MEDICAL DEVICE LOT #: 231380 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD GRAM NEGATIVE BACTERIA GROWTH AND COVERS THE GROWTH OF GRAM-POSITIVE GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTS FOR LOT: 231380 EXPIRING 30/01/2023 AS A POORLY SELECTIVE MEDIA, GRAM-NEGATIVE BACTERIA FREQUENTLY GROW, COVERING THE GROWTH OF GRAM-POSITIVE BACTERIA, AND SOMETIMES GRAM-POSITIVE BACTERIA ARE INHIBITED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD GRAM NEGATIVE BACTERIA GROWTH AND COVERS THE GROWTH OF GRAM-POSITIVE GROWTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTS FOR LOT: 231380, EXPIRING 30/01/2023 AS A POORLY SELECTIVE MEDIA, GRAM-NEGATIVE BACTERIA FREQUENTLY GROW, COVERING THE GROWTH OF GRAM-POSITIVE BACTERIA, AND SOMETIMES GRAM-POSITIVE BACTERIA ARE INHIBITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789391 BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown