BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE

    MDR report key: 11915360 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00925
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902222399
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: 2021-05-06 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 MAIN COMPONENT OF PREPARED PLATED MEDIA IS PURIFIED WATER. THE PURIFIED WATER IS HELD IN AN AGAR MATRIX IN THE MEDIA. RELEASE OF THE PURIFIED WATER AS THE MATRIX CONTRACTS DURING TEMPERATURE CYCLING AND PROGRESSION THROUGH SHELF LIFE IS REFERRED TO AS EXUDATION. AS MEDIA PROGRESSES THROUGH SHELF LIFE, SOME CONDENSATE WILL APPEAR INSIDE THE SLEEVES, DISHES OR ON THE AGAR SURFACE. THIS CONDENSATE OR EXCESSIVE MOISTURE OCCASIONALLY PRESENTS UPON REMOVAL FROM STORAGE AND PACKAGING. PLATES CAN BE INVERTED OVER THE LID AND ALLOWED TO DRY BEFORE INOCULATION WHEN CONDENSATE/EXCESSIVE MOISTURE IS NOTED. IT IS BEST TO DO THESE 2 TO 3 HOURS DIRECTLY BEFORE YOU INOCULATE THE PLATES. CONTROL OF THE TEMPERATURE CYCLING THAT OUR PRODUCT EXPERIENCES WHILE IN YOUR POSSESSION MAY HELP REDUCE THE AMOUNT OF FREE MOISTURE SEEN. POOLING OF WATER INSIDE THE SLEEVE IS NOT CONSIDERED A NORMAL AMOUNT OF EXCESSIVE MOISTURE. IF THIS IS OBSERVED AT YOUR SITE, PLEASE CONTACT TECHNICAL SERVICES AND DOCUMENT THE OCCURRENCE WITH PHOTOGRAPHS AS SOON AS POSSIBLE AFTER IT IS NOTICED. THE BATCH HISTORY RECORD FOR BATCH 1099123 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. SAMPLE 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 TYPICAL LEVELS. ALL PHYSICAL ATTRIBUTE AND BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER OUR INTERNAL PROCEDURES. THE PLATES IN QUESTION ARE NOT STERILE. THEY ARE TESTED FOR BIOBURDEN PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. HOWEVER, THIS DOES NOT ENSURE THAT THE END-USER WILL NOT RECEIVE A CONTAMINATED PLATE. THE COMPLAINT HISTORY WAS REVIEWED, AND FOUR OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION INCLUDING ANOTHER FOR A DIFFERENT SHIPMENT OF THIS BATCH. RETENTION SAMPLES FROM BATCH 1099123 WERE NOT AVAILABLE FOR INSPECTION. FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS A SHIPPING LABEL ADDRESSED TO THE CUSTOMER. ANOTHER PHOTO SHOWS THE SHIPPING CARTON OPENED WITH A 100PACK CARTON INSIDE OF IT. ONE OF THE BOTTOM CORNERS OF THE SHIPPING CARTON IS DENTED AND BOTH VISIBLE SIDE EDGES SHOW BUCKLING. ANOTHER PHOTO SHOWS 15 UNOEPNED SLEEVES OF BI-PLATES WITH SOME BLUE IN THE CHROMAGAR ORIENTATION MEDIUM IN AT LEAST ONE ONE PLATE OF AT LEAST SIX SLEEVES. THE LAST PHOTO SHOWS 17 UNOPENED SLEEVES FROM BATCH 1099123 WITH AT LEAST ONE PLATE IN NINE SLEEVES WITH BLUE IN THE CHROMAGAR ORIENTATION MEDIUM THERE ARE ALSO SIX PLATES IN THE PHOTO, BOTTOM SIDE UP, WITH GROWTH VISIBLE IN FOUR OF THE PLATES. NO TIME STAMPS CAN BE READ FROM THE PHOTOS AND ALL BLUE COLOR OF THE CHROMAGAR IS PRESUMED TO BE A REACTION TO GROWTH. RETURNS ALSO WERE RECEIVED FOR INVESTIGATION. THIRTY-EIGHT PLATES FROM BATCH 1099123 WERE RETURNED AS EIGHT LOOSE PLATES HELD TOGETHER WITH A RUBBER BAND IN A ZIPLOCK BAG AND THREE UNOPENED SLEEVES SHIPPED IN A BOX. PLATES WERE INSPECTED AND SURFACE AND SUBSURFACE BACTERIAL GROWTH WERE OBSERVED IN 24/38 PLATES RETURNED (TIME STAMPS 1138, 1143, 1146, 1158, 1349, 1514, 1515, 1517 AND 1531). TWO AFFECTED PLATES WERE SUBMITTED TO THE ID LAB AND PSEUDOMONAS FLUORESCENS AND STENOTROPHOMONAS RHIZOPHILA WERE IDENTIFIED. SPLASH OVER ON BOTH SIDES WERE OBSERVED IN 1/38 RETURNED PLATES. MEDIA SPLASH OVER IS A FILLING DEFECT WERE THE TWO MEDIA OF A BI-PLATE ARE MIXED IN AT LEAST ONE HALF OF THE BI-PLATE. THIS RESULTS IN MEDIA APPEARING DISCOLORED AND UNEVENLY FILLED HALVES OF THE BI-PLATE. NO CONDENSATION OR FREE MOISTURE WAS SEEN IN THE SLEEVES RETURNED. ONE RETURNED PLATE WAS BROKEN. BD SHIPS PRODUCT IN TEMPERATURE CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. DROPPING OF THE PLATES AND VIBRATIONS DURING SHIPPING CAN CAUSE BROKEN OR CRACKED PLATES. IT WAS NOTED IN THE PHOTOS PROVIDED THAT THE SHIPPING CARTON WAS DAMAGED. ISSUES WITH SHIPPING CAN BE DIRECTED TO CUSTOMER SERVICE. BD WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS. EXCESS MOISTURE CANNOT BE CONFIRMED FROM NEITHER THE RETURNS NOR PHOTOS. BROKEN PLATES CAN BE CONFIRMED, HOWEVER SHIPPING DAMAGE WAS NOTED. MEDIA SPLASH OVER AND CONTAMINATION CAN BE CONFIRMED. A CONTAMINATION TREND FOR BATCH 1099123 HAS BEEN IDENTIFIED. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) 3076308 HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND CORRECTIVE ACTIONS FOR CONTAMINATION IN THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 7 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. ADDITIONALLY, A PHYSICAL DEFECT WAS OBSERVED IN 7 PLATES 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 RECEIPT OF CONTAMINATED AND BROKEN PLATES FOR ITEM 222239 LOT 1099123 - PLATE BI CHROMAGAR ORIENT/TSA II SB. OF THE 1500 PLATES, 7 SLEEVES HAVE THE BLUE ORGANISM CONTAMINATION, 6 ARE SHOWING DARKER SPOTS ON SOME PLATES ON THE TSA AGAR SIDE (EITHER CONTAMINATION OR HEMOLYSIS ¿ WE CAN¿T TELL UNLESS WE OPEN THE SLEEVES), AND 3 HAVE BROKEN PLATES.  HERE ARE PICTURES OF WHAT CAME IN.  THERE¿S A LOT OF CONDENSATION ON THESE TOO.

    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 7 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR W/5% SHEEP BLOOD (TSA II)-I PLATE¿ CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. ADDITIONALLY, A PHYSICAL DEFECT WAS OBSERVED IN 7 PLATES 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 RECEIPT OF CONTAMINATED AND BROKEN PLATES FOR ITEM 222239 LOT 1099123 - PLATE BI CHROMAGAR ORIENT/TSA II SB. OF THE 1500 PLATES, 7 SLEEVES HAVE THE BLUE ORGANISM CONTAMINATION, 6 ARE SHOWING DARKER SPOTS ON SOME PLATES ON THE TSA AGAR SIDE (EITHER CONTAMINATION OR HEMOLYSIS ¿ WE CAN'T TELL UNLESS WE OPEN THE SLEEVES), AND 3 HAVE BROKEN PLATES.  HERE ARE PICTURES OF WHAT CAME IN.  THERE¿S A LOT OF CONDENSATION ON THESE TOO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808277 BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 1099123 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1