BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TRYPTICASE SOY AGAR W 5% SHEEP BLOOD - MACCONKEY II AGAR

    MDR report key: 11609338 · Received April 2, 2021

    Report

    Report Number
    1119779-2021-00603
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 11, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    10382902212918
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-03-17. H6: INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221291, 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 0345628 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 TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 0345628 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 0345628 WERE NOT AVAILABLE FOR INSPECTION. RETURNS WERE RECEIVED FOR INVESTIGATION. SEVENTEEN PLATES FROM BATCH 0345628 WERE RETURNED AS ONE UNOPENED SLEEVE (10 PLATES) AND SEVEN LOOSE, PARAFILMED PLATES SHIPPED IN A 20PACK CARTON (TIME STAMPS 1003 AND 1010). ALL SEVEN LOOSE PLATES HAS SURFACE AND SUBSURFACE BACTERIAL GROWTH ON BOTH MEDIA AND 2/10 PLATES FROM THE UNOPENED SLEEVE ALSO HAD BACTERIAL GROWTH. ONE OF THE AFFECTED PLATES WAS SUBMITTED TO THE ID LAB, AND PSEUDOMONAS FLUORESCENS WAS IDENTIFIED. NO PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT HAS BEEN CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR 3 BOXES WERE DISCOVERED TO BE CONTAMINATED. CUSTOMER DID NOT GRAM STAIN THE ORGANISMS, BUT STATES MOST WERE GRAM NEGATIVE BACILLI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS 3 BOXES OF 221291 PLATES THAT A FEW PLATES IN EACH CASE HAVE CONTAMINATION PRODUCT WAS STORED IN THE REFRIGERATOR AT 6 DEGREES C. THE SLEEVES ARE ALL CLOSED, BOXES WERE SEALED, CUSTOMER KEPT 8 PLATES, BUT WE THREW AWAY NUMEROUS PLATES. CUSTOMER STATES THAT WOULD BE 1 HERE AND THERE IN SOME OF THE SLEEVES, SOMETIMES MORE. CONTAMINATION WAS DISCOVERED BEFORE INOCULATION, UPON OPENING THE PACKAGE OF PLATES. CUSTOMER REPORTS THAT CONTAMINATION IS MOSTLY, MOSTLY ON TOP OF THE MEDIA, BUT THERE WERE SOME THAT WERE IN THE SIDE OF THE PLATE CUSTOMER DID NOT GRAM STAIN THE ORGANISMS, BUT STATES MOST WERE GRAM NEGATIVE BACILLI.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR, 3 BOXES WERE DISCOVERED TO BE CONTAMINATED. CUSTOMER DID NOT GRAM STAIN THE ORGANISMS, BUT STATES MOST WERE GRAM NEGATIVE BACILLI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS 3 BOXES OF 221291 PLATES THAT A FEW PLATES IN EACH CASE HAVE CONTAMINATION PRODUCT WAS STORED IN THE REFRIGERATOR AT 6 DEGREES C. THE SLEEVES ARE ALL CLOSED, BOXES WERE SEALED, CUSTOMER KEPT 8 PLATES, BUT WE THREW AWAY NUMEROUS PLATES. CUSTOMER STATES THAT WOULD BE 1 HERE AND THERE IN SOME OF THE SLEEVES, SOMETIMES MORE. CONTAMINATION WAS DISCOVERED BEFORE INOCULATION, UPON OPENING THE PACKAGE OF PLATES. CUSTOMER REPORTS THAT CONTAMINATION IS MOSTLY, MOSTLY ON TOP OF THE MEDIA, BUT THERE WERE SOME THAT WERE IN THE SIDE OF THE PLATE CUSTOMER DID NOT GRAM STAIN THE ORGANISMS, BUT STATES MOST WERE GRAM NEGATIVE BACILLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504394 BD BBL TRYPTICASE SOY AGAR W 5% SHEEP BLOOD - MACCONKEY II AGAR CULTURE MEDIA, NON-SELECTIVE & NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221291 0345628 10382902212918

    Patients

    Seq Age Sex Outcome Treatment
    1