BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL
Report
- Report Number
- 1119779-2022-00453
- Event Type
- Malfunction
- Date Received
- March 21, 2022
- Date of Event
- February 24, 2022
- Report Date
- January 3, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221174, MEDIA IS FORMULATED USING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN ISO CERTIFIED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED 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 1309270 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 1309270. RETENTION SAMPLES FROM BATCH 1309270 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. EACH PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 1309270 (TIME STAMP 2238) WITH MICROBIAL GROWTH. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR CONTAMINATION HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT 6 BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL PLATES WERE CONTAMINATED WITH COLONIES. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY COLLAGUES FEEDBACK THERE ARE COLONIES OBSERVED ON 7H10 PLATE (221174) LOT NO:1309270 EXP 21/03/22. TOTAL OF 6 CONTAMINATED PLATES FOR THIS LOT NUMBER."
IT WAS REPORTED THAT 6 BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL PLATES WERE CONTAMINATED WITH COLONIES. THERE WAS NO REPORT OF ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY COLLAGUES FEEDBACK THERE ARE COLONIES OBSERVED ON 7H10 PLATE (221174) LOT NO:1309270 EXP 21/03/22. TOTAL OF 6 CONTAMINATED PLATES FOR THIS LOT NUMBER.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 890598 | BD BBL¿ MIDDLEBROOK AND COHN 7H10 AGAR DEEP FILL | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL | JSG | BECTON, DICKINSON & CO. (SPARKS) | 1309270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |