BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PSEUDOSEL¿ AGAR

    MDR report key: 11820312 · Received May 13, 2021

    Report

    Report Number
    1119779-2021-00816
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 21, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 297882, PLATE PSEUDOSEL AGAR CETRIMIDE 10 EA, FOR BATCH NUMBER 1041548 AND COMPLAINT NUMBER (B)(4) FOR PERFORMANCE. DURING MANUFACTURING OF MATERIAL 297882, MEDIA IS FORMULATED USING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN ISO CERTIFIED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1041548 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS (COA). ROUTINE STABILITY STUDIES ARE PERFORMED ANNUALLY PER INTERNAL PROCEDURES FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS OF EACH PRODUCT. STABILITY DATA FOR THIS PRODUCT IS ON FILE. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1041548. RETENTION SAMPLES FROM BATCH 1041548 ARE NOT AVAILABLE FOR INSPECTION. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ PSEUDOSEL¿ AGAR PLATE FAILED GROWTH PROMOTION. IT WAS REPORTED THAT FAILED GROWTH PROMOTION. TS 0751. ATCC STRAIN 9027.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE USING BD BBL¿ PSEUDOSEL¿ AGAR PLATE FAILED GROWTH PROMOTION. IT WAS REPORTED THAT FAILED GROWTH PROMOTION. TS 0751, ATCC STRAIN 9027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715061 BD BBL¿ PSEUDOSEL¿ AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1041548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown