BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
Report
- Report Number
- 1119779-2022-00185
- Event Type
- Malfunction
- Date Received
- February 2, 2022
- Date of Event
- January 19, 2022
- Report Date
- December 12, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSO
- UDI-DI
- 10382902212406
- PMA / PMN Number
- K945569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6 INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 221240, 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 1288048 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 NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1288048. RETENTION SAMPLES FROM BATCH 1288048 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS THE BOTTOM OF TWO PLATES FROM BATCH 1288048 (TIME STAMP 0748) WITH COLONIES GROWING ON EACH PLATE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR CONTAMINATION WERE IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT HAS BEEN REPORTED THAT THE BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF CONTAINING CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING CONTAMINATION ON THEIR PLATES.
IT HAS BEEN REPORTED THAT THE BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF CONTAINING CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING CONTAMINATION ON THEIR PLATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233794 | BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST | JSO | BECTON, DICKINSON & CO. (SPARKS) | 221240 | 1288048 | 10382902212406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |