BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ XLD AGAR

    MDR report key: 12084255 · Received June 29, 2021

    Report

    Report Number
    1119779-2021-01073
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 1, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902212840
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-08. H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221284, PLATE XLD AGAR 100 EA, BATCH NUMBER 1095077 AND COMPLAINT NUMBER 3002954 FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221284, 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 1095077 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 ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 1095077 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1095077 WERE NOT AVAILABLE FOR INSPECTION. ONE HUNDRED PLATES FROM BATCH 1095077 WERE RETURNED AS TEN UNOPENED SLEEVES SHIPPED IN A RETAPED 100PACK CARTON (NUMBER 0059, TIME STAMPS 1029, 1031, 1032). PLATES WERE INSPECTED AND 28/100 PLATES HAD SURFACE BACTERIAL GROWTH. AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER STATED PLATES WERE CONTAMINATED, PRIOR TO OPENING. CUSTOMER DID NOT KNOW THE TYPE OF CONTAMINATION, BUT SAID THERE WERE YELLOW AREAS ON THE MEDIA. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ XLD AGAR CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER STATED PLATES WERE CONTAMINATED, PRIOR TO OPENING. CUSTOMER DID NOT KNOW THE TYPE OF CONTAMINATION, BUT SAID THERE WERE YELLOW AREAS ON THE MEDIA. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984850 BD BBL¿ XLD AGAR CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON, DICKINSON & CO. (SPARKS) 221284 1095077 10382902212840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown