BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD

    MDR report key: 22667068 · Received July 30, 2025

    Report

    Report Number
    1119779-2025-02089
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    December 22, 2023
    Report Date
    June 19, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902212772
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : DURING MANUFACTURING OF MATERIAL 221277, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES 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 3296800 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 WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. PHENYLETHYL ALCOHOL W/ 5% SB IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, THERE ARE NO OTHER COMPLAINTS TAKEN ON THIS BATCH 3296800 FOR THIS DEFECT. THERE WERE NO RETENTION SAMPLES AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. TWO PHOTOS WERE RECEIVED, ONE PHOTO SHOWS THE PLATE PRINT: 3296800, TIME STAMP 23:46. THE SECOND PHOTO SHOWS A VISIBLY STREAKED PLATE WITH GROWTH. OBSERVATIONS ABOUT PERFORMANCE CANNOT BE MADE FROM PHOTOS. NO RETURNS OR RETAINS WERE AVAILABLE FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD, A PLATE DID NOT SUPPRESS GROWTH OF GRAM NEGATIVES. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445676 BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON & CO. (SPARKS) 3296800 10382902212772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown