BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿

    MDR report key: 12685956 · Received October 22, 2021

    Report

    Report Number
    1119779-2021-01703
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 27, 2021
    Report Date
    August 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902222399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 222239, 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 1211703 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. THEY ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1211703. NO RETENTION SAMPLES FROM BATCH 1211703 FOR WERE AVAILABLE FOR INSPECTION. TEN PLATES FROM BATCH 1211703 WERE RETURNED AS ONE UNOPENED SLEEVE SHIPPED IN A SMALL BOX. PLATES WERE INSPECTED AND 1/10 PLATES HAD A BROKEN LID, 1/10 PLATES HAD SURFACE AND SUBSURFACE BACTERIAL GROWTH ON THE CHROMAGAR ORIENTATION MEDIA, AND 0/10 PLATES HAD ANY COLOR VARIATION OBSERVED (TIME STAMP 0945). THE OBSERVED GROWTH WAS SUBMITTED TO THE ID LAB AND IDENTIFIED AS PSEUDOMONAS FLUORESCENS. FOUR PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO FEATURES A SLEEVE LABEL FROM BATCH 1211703 FOR BATCH VERIFICATION. ANOTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1211703 (TIME STAMP 1010) WITH MICROBIAL GROWTH IN THE CHROMAGAR ORIENTATION MEDIA VISIBLE. THE THIRD PHOTO SHOWS THE SIDE OF A SLEEVE WITH WHAT APPEARS TO BE MICROBIAL GROWTH IN ONE OF THE CHROMAGAR ORIENTATION MEDIA OF ONE PLATE. THE LAST PHOTO SHOWS THREE SLEEVES FROM BATCH 1211703 (TIME STAMP 1019) WITH NO DEFECTS OBSERVABLE AND ONE PLATE FROM BATCH 1211703 (TIME STAMP 1010) WITH MICROBIAL GROWTH IN THE CHROMAGAR ORIENTATION MEDIA. NO RETURNS OR PHOTOS SHOWED COLOR VARIATION IN THE MEDIA; SO THIS COMPLAINT CANNOT BE CONFIRMED FOR COLOR VARIATION. THIS COMPLAINT CAN BE CONFIRMED FOR BROKEN PLATES AND CONTAMINATION BY THE RETURNS AND PHOTOS. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 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. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ 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 CONTAMINATION ON PRODUCT 22239 WITH LOT#: 1211703".

    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¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ 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 CONTAMINATION ON PRODUCT 22239 WITH LOT#: 1211703".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580145 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR PLATE¿ CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1211703 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown