BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿; CHROMAGAR¿; ORIENT/TSA II W/5% SB

    MDR report key: 11914627 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00919
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 10, 2021
    Report Date
    November 2, 2021
    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

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 5/12/2021. H.6. INVESTIGATION: 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 1106169 WAS SATISFACTORY AT TIME OF RELEASE AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING. A SAMPLE OF PLATES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR APPROXIMATELY 72 HOURS. ALL PHYSICAL ATTRIBUTE AND 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 OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1106169 FOR CONTAMINATION AND BROKEN PLATES INCLUDING TWO OTHERS FROM KAISER PERMANENTE FOR DIFFERENT SHIPMENTS. RETENTION SAMPLES FROM BATCH 1106169 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. FOUR UNOPENED SLEEVES (40 PLATES) FROM BATCH 1106169 WERE RETURNED IN A BOX (TIME STAMPS 0954, 1203, 1204 AND 1208). PLATES WERE INSPECTED AND 6/40 PLATES HAD SURFACE AND SUBSURFACE BACTERIA GROWTH ON BOTH MEDIA. AFFECTED PLATES WERE SUBMITTED TO THE ID LAB, AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. THREE BROKEN PLATES ALSO WERE FOUND IN THE RETURN SAMPLES. THREE PHOTOS ALSO WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS FIVE SLEEVES FROM BATCH 1106169 WITH AT LEAST ONE PLATE WITH THE CHROMAGAR ORIENTATION MEDIUM TURNED BLUE. THIS COULD BE DUE TO MICROBIAL GROWTH IN THE AGAR. ANOTHER PHOTO SHOWS A SLEEVE FROM BATCH 1106169 WITH ONE BROKEN PLATE INSIDE OF THE SLEEVE. THE LAST PHOTO SHOWS NINE SLEEVES OF BI-PLATES WITH CRACKS VISIBLE IN THE PLATE LIDS IN SOME OF THE SLEEVES. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION AND BROKEN PLATES. DUE TO THE NUMBER OF COMPLAINTS TAKEN FOR CONTAMINATION FOR MATERIAL 222239, CAPA#3076308 HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND CORRECTIVE ACTIONS OF THE CONTAMINATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE DEFECTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿; CHROMAGAR¿; ORIENT/TSA II W/5% SB 9 PLATES HAD VISIBLE CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS RECEIPT OF 222239 LOT 1106169 - PLATE BI CHROMAGAR ORIENT/TSA II SB 100 WITH VISIBLE CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿; CHROMAGAR¿; ORIENT/TSA II W/5% SB 9 PLATES HAD VISIBLE CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS RECEIPT OF 222239 LOT 1106169 - PLATE BI CHROMAGAR ORIENT/TSA II SB 100 WITH VISIBLE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808231 BD BBL¿; CHROMAGAR¿; ORIENT/TSA II W/5% SB CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1106169 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown