BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿)

    MDR report key: 14735232 · Received June 17, 2022

    Report

    Report Number
    1119779-2022-00894
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 6, 2022
    Report Date
    February 17, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    NA
    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

    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

    INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221780, 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 FOR BATCH 2033730 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. GROUP A SELECTIVE STREP AGAR WITH 5% SHEEP BLOOD 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, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2033730. RETENTION SAMPLES FROM BATCH 2033730 WERE NOT AVAILABLE FOR INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS NO GROWTH ON THE PLATE OF BD PRODUCT, BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿). THERE WAS ONE OCCURRENCE IN THIS EVENT AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO GROWTH ON THE STREPT AGAR PLATE AFTER THE 24 HOUR INCUBATION WITH CATALOG# 221780, LOT# 2033730."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS NO GROWTH ON THE PLATE OF BD PRODUCT, BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿). THERE WAS ONE OCCURRENCE IN THIS EVENT AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO GROWTH ON THE STREPT AGAR PLATE AFTER THE 24 HOUR INCUBATION WITH CATALOG# 221780, LOT# 2033730".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813205 BD BBL¿ GROUP A SELECTIVE STREP AGAR W/5% SHEEP BLOOD (SSA¿) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2033730

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown