BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)

    MDR report key: 12896679 · Received November 30, 2021

    Report

    Report Number
    1119779-2021-01893
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 2, 2021
    Report Date
    September 6, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    NA
    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

    INITIAL REPORTER PHONE#: (B)(6). 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

    H.6 INVESTIGATION SUMMARY; THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, FOR BATCH NUMBER 1216781 AND COMPLAINT NUMBER (B)(4) FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221278, 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 1216781 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. AFFECTED PRODUCT DOES NOT HAVE ANY STERILITY CLAIMS; THE PRODUCT IS TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT IT CONFORMS TO PRODUCT SPECIFICATIONS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1216781. RETENTION SAMPLES FROM BATCH 1216781 WERE NOT AVAILABLE FOR INSPECTION. THIRTY PLATES FROM BATCH 1216781 WERE RETURNED AS THREE UNOPENED SLEEVES SHIPPED IN A BOX WITH AIR BUBBLES AND BUBBLE WRAP. PRIOR TO INSPECTION, SLEEVES RETURNED WERE INCUBATED AT 20 TO 25 DEGREES C. AT SEVEN DAYS INCUBATION, PLATES WERE INSPECTED 0/30 PLATES HAD MICROBIAL GROWTH (TIME STAMPS 1631 AND 1632). NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) PLATES WERE CONTAMINATED WITH FUNGI. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT THEY ARE PLACING AN UNINOCULATED PLATE IN THEIR INCUBATOR TO AS A NEGATIVE CONTROL STERILITY CHECK. ALTHOUGH THE PLATE HAS NOT BE INOCULATED WITH ANYTHING THEY ARE SEEING GROWTH ON THE PLATES. THIS HAS HAPPENED ON AN ESTIMATED 10-15 PLATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) PLATES WERE CONTAMINATED WITH FUNGI. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT THEY ARE PLACING AN UNINCOLUATED PLATE IN THEIR INCUBATOR TO AS A NEGATIVE CONTROL STERILITY CHECK. ALTHOUGH THE PLATE HAS NOT BE INOCULATED WITH ANYTHING THEY ARE SEEING GROWTH ON THE PLATES. THIS HAS HAPPENED ON AN ESTIMATED 10-15 PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797732 BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1216781

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown