BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD

    MDR report key: 16362584 · Received February 13, 2023

    Report

    Report Number
    1119779-2023-00124
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 11, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    10382902212772
    PMA / PMN Number
    PREAMENDMENT
    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 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 FOR BATCH 2341469 WAS SATISFACTORY PER INTERNAL PROCEDURES. 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 2341469. RETENTION SAMPLES FROM BATCH 2341469 WERE NOT AVAILABLE FOR INSPECTION. THIRTY PLATES FROM BATCH 2341469 WERE RETURNED AS THREE UNOPENED SLEEVES SHIPPED IN A BOX (TIME STAMPS 0202, 0203 AND 0208). PLATES WERE INSPECTED AND 12/30 PLATES HAD SURFACE AND SUBSURFACE BACTERIAL GROWTH. ONE AFFECTED PLATE WAS SUBMITTED TO THE ID LAB AND PSYCHROBACTER PULMONIS WAS IDENTIFIED. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE AGAR SURFACE OF FOUR PLATES, EACH WITH SUBSURFACE BACTERIAL GROWTH. ANOTHER PHOTO FEATURES THE PLATE PRINT ON THE BOTTOM OF A PLATE FROM BATCH 2341469 (TIME STAMP 0215). THE LAST PHOTO SHOWS THE BOTTOM OF FOUR PLATES FROM BATCH 2341469 (TIME STAMPS 0214 AND 0215) WITH SUBSURFACE GROWTH VISIBLE ON THREE PLATES. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE 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. IMPROVEMENT IN OBSERVATION OF CONTAMINATION IS EXPECTED AS THE CAPA PROGRESSES. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PIT WAS REPORTED THAT WHILE USING THE BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MOLD ON CATALOG 221277, LOT#2341469 THAT WERE RECEIVED ON 31ST JANUARY.

    Description of Event or Problem · 0

    PIT WAS REPORTED THAT WHILE USING THE BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MOLD ON CATALOG 221277, LOT#2341469 THAT WERE RECEIVED ON 31ST JANUARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388033 BD BBL¿ PHENYLETHYL ALCOHOL AGAR WITH 5% SHEEP BLOOD SEE H.10 JSJ BECTON, DICKINSON & CO. (SPARKS) 221277 2341469 10382902212772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown