BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO PURPLE BROTH BASE

    MDR report key: 11877557 · Received May 25, 2021

    Report

    Report Number
    1119779-2021-00882
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING CONSISTS OF DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, SOLUTION APPEARANCE, PH AND CULTURAL RESPONSE WITH ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO CONFIRMED COMPLAINTS ON THIS PRODUCT FOR THE DEFECT IN QUESTION. NO RETURNS WERE RECEIVED. THE COMPLAINT STATES THAT PURPLE BROTH BASE IS USED IN CONJUNCTION WITH AGAR AND RHAMNOSE OR XYLOSE AND OBTAINING UNDESIRED POSITIVE REACTIONS WITH LISTERIA GRAYI. LISTERIA GRAYI IS NOT TESTED FOR RELEASE OF THIS PRODUCT; CONSEQUENTLY, BD DOES NOT HAVE ACCESS TO THIS ORGANISM AND IS UNABLE TO DUPLICATE THE CUSTOMER¿S APPLICATION. IN ADDITION, BD DOES NOT HAVE ANY HISTORICAL DATA RELATED TO THE PERFORMANCE OF LISTERIA IN PURPLE BROTH BASE. THIS COMPLAINT CANNOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD DIFCO¿ PURPLE BROTH BASE ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT UNDESIRED POSITIVE REACTION WHEN STREAKING LISTERIA GRAYI. CUSTOMER PROBLEM: CUSTOMER REPORTED USING THIS PRODUCT 222710 (2 EA) LOT 9231550 (PO# (B)(4)) TO MAKE XYLOSE AND RHAMNOSE AGARS, THE AGARS ARE PRODUCING AN UNDESIRED POSITIVE REACTION WHEN STREAKING LISTERIA GRAYI. THIS PROBLEM IS ONLY OCCURRING WITH THE AFOREMENTIONED COMBINATION AND THE INVESTIGATION CONDUCTED IN OUR LAB LED US TO TRY MAKING THE PURPLE BROTH BASE FROM ITS INDIVIDUAL COMPONENTS WHICH SOLVED THE ISSUE. WE CURRENTLY HAVE TWO BOTTLES OF THE SAME LOT, BOTH OF WHICH PRODUCED THE SAME UNDESIRED RESULT WITH L.GRAYI ON RHAMNOSE AND XYLOSE.  ALL OTHER CARBOHYDRATE SOLUTIONS USED IN CONJUNCTION WITH THE ABOVE LOT OF PURPLE BROTH BASE PRODUCED SATISFACTORY RESULTS WHEN STREAKING THEIR RESPECTIVE ORGANISMS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD DIFCO¿ PURPLE BROTH BASE ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT UNDESIRED POSITIVE REACTION WHEN STREAKING LISTERIA GRAYI. ¿ CUSTOMER PROBLEM: CUSTOMER REPORTED USING THIS PRODUCT 222710 (2 EA) LOT 9231550 (PO# (B)(4)) TO MAKE XYLOSE AND RHAMNOSE AGARS, THE AGARS ARE PRODUCING AN UNDESIRED POSITIVE REACTION WHEN STREAKING LISTERIA GRAYI. THIS PROBLEM IS ONLY OCCURRING WITH THE AFOREMENTIONED COMBINATION AND THE INVESTIGATION CONDUCTED IN OUR LAB LED US TO TRY MAKING THE PURPLE BROTH BASE FROM ITS INDIVIDUAL COMPONENTS WHICH SOLVED THE ISSUE. WE CURRENTLY HAVE TWO BOTTLES OF THE SAME LOT, BOTH OF WHICH PRODUCED THE SAME UNDESIRED RESULT WITH L.GRAYI ON RHAMNOSE AND XYLOSE.  ALL OTHER CARBOHYDRATE SOLUTIONS USED IN CONJUNCTION WITH THE ABOVE LOT OF PURPLE BROTH BASE PRODUCED SATISFACTORY RESULTS WHEN STREAKING THEIR RESPECTIVE ORGANISMS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775618 BD DIFCO PURPLE BROTH BASE CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 9231550

    Patients

    Seq Age Sex Outcome Treatment
    1