BD BBL¿ MACCONKEY II AGAR
Report
- Report Number
- 1119779-2023-00836
- Event Type
- Malfunction
- Date Received
- August 3, 2023
- Date of Event
- July 5, 2023
- Report Date
- December 12, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- UDI-DI
- 10382902212703
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221270, 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 3150547 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3150547. RETENTION SAMPLES FROM BATCH 3150547 WERE NOT AVAILABLE FOR INSPECTION. NO RETURNS OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PLATE DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PLATE DEFECTS. THE DEFECT DESCRIPTION FOR THIS COMPLAINT STATES THAT ¿SPOTS¿ ON BD PLATES ARE AFFECTING THE USAGE OF THE PLATES ON THE ISOPLATER INSTRUMENT. IF THOSE SPOTS REPORTED ARE THE MOLDING GATE ON THE PLATE BOTTOM. THE BELOW INFORMATION WILL APPLY. DISHES FOR PREPARED PLATED MEDIA MANUFACTURED IN SPARKS, MD ARE MOLDED BY BD. MOLDS HAVE A LIFE SPAN AND ARE CONTINUOUSLY REPLACED TO ENSURE DISHES HAVE CONSISTENT QUALITY. IN RECENT MOLD REPLACEMENTS, THE MOLDING GATE, WHERE THE PLASTIC MATERIAL ENTERS THE MOLD, HAS BEEN COMBINED WITH THE FROSTED SECTION AT THE EDGE OF THE DISH BOTTOM. THERE HAVE BEEN NO DIMENSIONAL CHANGES TO THE DISHES. THERE SHOULD BE NO EFFECT WHEN USING THE PLATES FOR MANUAL MICROBIOLOGY METHODS. PREPARED PLATED MEDIA MADE FROM THESE DISHES WITH THE COMBINED GATE AND FROSTING HAVE BEEN TESTED USING BD¿S AUTOMATED TECHNOLOGY SYSTEM, BD KIESTRA, AND THERE IS NO EFFECT TO THE PERFORMANCE OF THE INSTRUMENT SYSTEMS. PREVIOUS VERSIONS OF THE MOLD, WHERE THE MOLDING GATE AND FROSTING ARE LOCATED SEPARATELY ON THE DISH BOTTOM, ARE STILL IN USE. ALL DISHES OF THIS TYPE AND DIMENSIONS ARE CONSIDERED EQUIVALENT. BD DOES NOT SEPARATE OR SEGREGATE PRODUCT BY DISH MOLD EMPLOYED. DISHES WITH THE COMBINED GATE AND FROSTING HAVE BEEN USED IN PREPARED PLATED MEDIA SINCE MARCH 2022. BD CANNOT MAKE ANY CLAIMS ABOUT THE USE OF PREPARED PLATED MEDIA ON INSTRUMENTS OR EQUIPMENT NOT MANUFACTURED BY BD. BD HAS BEEN MADE AWARE OF DISHES WITH THE COMBINED FROSTING AND GATE HAVE BEEN CAUSING ERRORS IN VISTA TECHNOLOGY INC'S ISOPLATER INSTRUMENT. WHILE BD CANNOT GUARANTEE THE USE OF BD PRODUCTS WITH A NON-BD INSTRUMENT, BD HAS MADE MULTIPLE ATTEMPTS TO CONTACT VISTA TECHNOLOGY TO GAIN UNDERSTANDING OF THEIR INSTRUMENT'S CHALLENGES WITH BD DISHES WITH THE COMBINED GATE AND FROSTING. BD FINALLY RECEIVED A RESPONSE LETTER IN JANUARY 2023 STATING SALES OF THE ISOPLATER INSTRUMENT HAVE CEASED AND THAT VISTA TECHNOLOGIES WILL CEASE COMMERCIAL OPERATIONS IN JULY 2023 AS THE COMPANY MOVES TO CEASE ALL OPERATIONS. WHILE THE LETTER FROM VISTA TECHNOLOGY ALSO STATED THAT SERVICE AND SUPPORT FOR ISOPLATER INSTRUMENTS IN THE FIELD ARE CONTINUING, THEY HAVE NOT RESPONDED TO BD'S REQUESTS TO DISCUSS THE ISOPLATER'S CHALLENGES WITH BD DISHES THAT HAVE THE COMBINED GATE AND FROSTING. BD STRIVES TO DO WHAT IS RIGHT. BD HAS EVALUATED THAT THE FROSTING AND GATE WILL CONTINUE TO BE COMBINED IN THE MOLD REFURBISHMENT PROCESS, WHERE MOLDS ARE CONTINUOUSLY REPLACED TO ENSURE DISHES HAVE CONSISTENT QUALITY. HOWEVER, DUE TO THE FEEDBACK RECEIVED CONCERNING USABILITY IN END-USERS' ISOPLATER INSTRUMENT, THE MOLD WITH THE COMBINED FROSTING AND GATE HAS BEEN MODIFIED. THE GATE WAS OBVIOUSLY VISIBLE IN THE FROSTING BECAUSE IT WAS A CLEAR CIRCLE. THE MOLD WAS MODIFIED TO FROST THE CIRCLE OF THE GATE SO THAT TWO CONCENTRIC, FROSTED CIRCLES DENOTE THE GATE LOCATION. AS THE MOLD REFURBISHMENT PROCESS CONTINUES, MOLDS WILL HAVE THE GATE LOCATED IN THE FROSTED SECTION BUT THE GATE WILL ALSO BE FROSTED. THIS MODIFICATION OF THE FROSTED GATE LOCATED IN THE FROSTED SECTION WAS TESTED IN BD'S AUTOMATED TECHNOLOGY SYSTEM, BD KIESTRA, AND THERE IS NO EFFECT TO THE PERFORMANCE OF THE INSTRUMENT SYSTEM. PLEASE NOTE, VISTA TECHNOLOGY HAS NOT PROVIDED ANY INFORMATION TO BD OR PARTICIPATED IN ANY DISCUSSION WITH BD ABOUT THIS ISSUE. BD MADE THIS MODIFICATION ON AN ASSUMPTION THAT THE ISOPLATER INSTRUMENT COULD BE CHALLENGED BECAUSE OF THE OBVIOUS VISIBLE DIFFERENCE OF THE CLEAR GATE WITHIN THE FROSTING. BD ALSO TOOK THE STEP TO IDENTIFY A CUSTOMER WITH AN ISOPLATER INSTRUMENT WHO WAS WILLING TO TEST PLATES WITH THE FROSTED GATE WITHIN THE FROSTED SECTION. THE CUSTOMER REPORTED TO BD THAT THE PLATES WITH THE FROSTED GATE WITHIN THE FROSTED SECTION DID NOT CAUSE ERRORS IN THE ISOPLATER INSTRUMENT. BD IS OPTIMISTIC THAT THE ACTIONS TAKEN BY BD HAVE MITIGATED THE CHALLENGES OF BD DISHES WITH THE COMBINED GATE AND FROSTING IN THE ISOPLATER INSTRUMENT. PLEASE BE AWARE THAT BD HAS INVENTORY OF DISHES WITH THE COMBINED CLEAR GATE AND FROSTING AND END-USERS MAY CONTINUE TO SEE THESE DISHES WITH THE COMBINED CLEAR GATE AND FROSTING AS INVENTORY IS EXHAUSTED AND PRODUCT BATCHES MOVE THROUGH SHELF LIFE. THESE DIFFERING DISHES MAY BE ENCOUNTERED WITHIN THE SAME BATCH OF MATERIAL. BD DOES NOT SEPARATE OR SEGREGATE PRODUCT BY DISH MOLD EMPLOYED. BD CANNOT FURTHER ADDRESS THE ISOPLATER INSTRUMENT ISSUE WITHOUT THE COOPERATION OF THE ISOPLATER'S MANUFACTURER, VISTA TECHNOLOGY. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR HAVE SPOTS ON THE PLATE PREVENTING FROM USE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED: CUSTOMER REPORTS THERE IS SPOTS ON THE PLATE THAT PREVENT THE USE OF OUR ISOPLATER INSTRUMENT.
IT WAS REPORTED THAT BD BBL¿ MACCONKEY II AGAR HAVE SPOTS ON THE PLATE PREVENTING FROM USE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED: CUSTOMER REPORTS THERE IS SPOTS ON THE PLATE THAT PREVENT THE USE OF OUR ISOPLATER INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1467028 | BD BBL¿ MACCONKEY II AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 3150547 | 10382902212703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |