BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR

    MDR report key: 19886828 · Received August 1, 2024

    Report

    Report Number
    9680577-2024-00022
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO UPDATE THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST BD BBL CHROMAGAR ORIENTATION AGAR, CATALOG NUMBER 257481, LOT NUMBER 4099883 WITH RESPECT TO A PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER DETECTED GROWTH OF DARK BLUE COLONIES SUSPICIOUS OF BEING KLEBSIELLA, BUT WHEN THEY DO AN API TEST THE IDENTIFICATION STATES E. COLI. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR COMPLAINT WAS IDENTIFIED FOR THIS CATALOG NUMBER. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESS PARAMETERS WERE DETECTED. RELEASE TESTING BY THE QC DEPARTMENT WAS SATISFACTORY. INITIAL SAMPLE ANALYSIS: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 4099883 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION. IN ADDITION TO THE QUALITY RELEASE TEST PROTOCOL E. COLI ATCC 11775 AND E. COLI ATCC 35218 WERE TESTED ON CATALOG NUMBER 257481, LOT NUMBER 4099883. BOTH ADDITIONAL TEST STRAINS SHOWED ROSE TO PINK COLONIES, AFTER INCUBATION AEROBICALLY FOR 24 H AT 35-37 °C IN THE DARK. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. A PICTURE SAMPLE, PROVIDED BY THE CUSTOMER, SHOW A PLATE OF LOT 4099883 WITH GROWTH OF BLUE COLONIES. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. IN ADDITION, NO OTHER CUSTOMER HAS RAISED A SIMILAR COMPLAINT FOR THIS LOT NUMBER. WE CONSIDER THE OCCURRENCE A SINGLE EVENT. PLEASE TAKE CARE THAT THE CHROMAGAR ORIENTATION PLATES SHOULD BE STORED IN THE DARK, AS THIS MAY HAVE AN INFLUENCE ON THE RESULT. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION ON RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED. ALL PREPARED MEDIA MUST BE STORED IN THE DARK. IF EXPOSED TO ARTIFICIAL LIGHT, SUNLIGHT, OR UV LIGHT FOR A LONGER TIME, THE PERFORMANCE OF ALL MEDIA MAY BE REDUCED. SEVERAL MEDIA, SUCH AS CHROMOGENIC MEDIA, ARE ESPECIALLY SENSITIVE TO STRONG ILLUMINATION BEFORE AND DURING INCUBATION. BD REGRETS THE INCONVENIENCES YOU EXPERIENCED AND WILL CONTINUE TO MONITOR SIMILAR INCOMING COMPLAINTS.

    Additional Manufacturer Narrative · 0

    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 WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR THAT COLONIES HAVE AN ATYPICAL DARK BLUE APPEARANCE. GROWTH IS SUSPECTED TO BE KLEBSIELLA BUT IS IDENTIFIED AS E.COLI. RESULTS WERE DELAYED BUT THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR THAT COLONIES HAVE AN ATYPICAL DARK BLUE APPEARANCE. GROWTH IS SUSPECTED TO BE KLEBSIELLA BUT IS IDENTIFIED AS E.COLI. RESULTS WERE DELAYED BUT THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885669 BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON DICKINSON GMBH 4099883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown