BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ AGAR, GRANULATED

    MDR report key: 14604647 · Received June 6, 2022

    Report

    Report Number
    1119779-2022-00820
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS MDR SHOULD BE CONSIDERED CANCELLED. THIS PRODUCT WAS DETERMINED TO BE FOR LAB USE ONLY AND IS NOT SOLD AS A MEDICAL DEVICE IN THE US. THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD DIFCO¿ AGAR, GRANULATED THERE WAS ALTERED PHENOTYPIC GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ALTERED PHENOTYPIC GROWTH WITH THEIR 214530 AGAR FROM LOT 0139161. CUSTOMER STATES AGAR IS PRODUCING AN ALTERED GROWTH PHENOTYPE FOR ONE OF THEIR ORGANISMS. WHEN LB AND TSA PLATES MADE WITH THIS AGAR ARE USED TO CULTURE SALMONELLA ENTERICA SUBSP ENTERITIDIS, S. ENTERITIDIS DISPLAYS A STRESS-ASSOCIATED, FILAMENTOUS CELLULAR MORPHOLOGY (DETERMINED BY GRAM STAINING) AND IRREGULAR COLONY MORPHOLOGY (INCONSISTENT COLONY SIZE AND COLOR). CUSTOMER HAS TESTED A VARIETY OF POSSIBLE SOURCES, INCLUDING THE WATER, GLASSWARE, AUTOCLAVE, AND NUTRIENT SOURCE, AND ARE CONFIDENT IN OUR ASSESSMENT THAT THE ISSUE IS CAUSED BY THIS LOT OF DIFCO AGAR. USING A DIFFERENT LOT NUMBER OF THE SAME PRODUCT DOES NOT REPRODUCE THIS ISSUE. CUSTOMER ALSO TRIED OTHER ORGANISMS ON THE SAME MEDIA AND SAW TYPICAL GROWTH. CUSTOMER WANTED TO REACH OUT AND INFORM BD THAT THERE MAY BE AN ISSUE WITH THIS LOT. SINCE THE ISSUE WAS ONLY OBVIOUS WITH SOME SPECIES OF BACTERIA AND NOT OTHERS, THE ISSUE MIGHT BE HAVING ¿INVISIBLE¿ EFFECTS ON EXPERIMENTAL OUTCOMES, OR MAY HAVE RESULTED IN DATA THAT IS NOT RELIABLE OR REPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD DIFCO¿ AGAR, GRANULATED THERE WAS ALTERED PHENOTYPIC GROWTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING ALTERED PHENOTYPIC GROWTH WITH THEIR 214530 AGAR FROM LOT 0139161. CUSTOMER STATES AGAR IS PRODUCING AN ALTERED GROWTH PHENOTYPE FOR ONE OF THEIR ORGANISMS. WHEN LB AND TSA PLATES MADE WITH THIS AGAR ARE USED TO CULTURE SALMONELLA ENTERICA SUBSP ENTERITIDIS, S. ENTERITIDIS DISPLAYS A STRESS-ASSOCIATED, FILAMENTOUS CELLULAR MORPHOLOGY (DETERMINED BY GRAM STAINING) AND IRREGULAR COLONY MORPHOLOGY (INCONSISTENT COLONY SIZE AND COLOR). CUSTOMER HAS TESTED A VARIETY OF POSSIBLE SOURCES, INCLUDING THE WATER, GLASSWARE, AUTOCLAVE, AND NUTRIENT SOURCE, AND ARE CONFIDENT IN OUR ASSESSMENT THAT THE ISSUE IS CAUSED BY THIS LOT OF DIFCO AGAR. USING A DIFFERENT LOT NUMBER OF THE SAME PRODUCT DOES NOT REPRODUCE THIS ISSUE. CUSTOMER ALSO TRIED OTHER ORGANISMS ON THE SAME MEDIA AND SAW TYPICAL GROWTH. CUSTOMER WANTED TO REACH OUT AND INFORM BD THAT THERE MAY BE AN ISSUE WITH THIS LOT. SINCE THE ISSUE WAS ONLY OBVIOUS WITH SOME SPECIES OF BACTERIA AND NOT OTHERS, THE ISSUE MIGHT BE HAVING ¿INVISIBLE¿ EFFECTS ON EXPERIMENTAL OUTCOMES, OR MAY HAVE RESULTED IN DATA THAT IS NOT RELIABLE OR REPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158647 BD DIFCO¿ AGAR, GRANULATED SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 0139161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown