BD BBL¿ MACCONKEY II AGAR
Report
- Report Number
- 1119779-2022-00089
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- January 5, 2022
- Report Date
- October 3, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- UDI-DI
- 10382902212703
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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.
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 1285612 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 THREE OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 1285612 FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1285612 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. BOTH PHOTOS ARE SIMILAR; EACH SHOWS THE BOTTOM OF TWO PLATES FROM BATCH 1285612 (TIME STAMPS 0738 AND 0739) WITH SURFACE BACTERIAL COLONIES ON EACH PLATE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. A TREND WAS IDENTIFIED FOR CONTAMINATION AND INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. A CAPA (CORRECTIVE AND PREVENTATIVE ACTIONS) HAS BEEN INITIATED AND INVOLVES IMPLEMENTING ADDITIONAL CLEANING EVENTS AND EVALUATION OF MANUFACTURING PROCEDURES FOCUSED ON IN-PROCESS BIOBURDEN REDUCTION. ADDITIONAL TRAININGS ARE PLANNED WITH AN ONGOING TRAINING REVIEW FOR CLEANING PROCESSES. THIS COMPLAINT CAN BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. RISK MANAGEMENT FILE REVIEW ASSESSED THE POTENTIAL RISK FOR THE DEFECT AS SEVERITY S1 PER BALTRMPPMSELECTIVEAPH, REV 02, ID 6.13.
IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND EXPERIENCING 10 OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE'S CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 1285612.
IT HAS BEEN REPORTED THAT THE BD BBL¿ MACCONKEY II AGAR HAS BEEN FOUND EXPERIENCING 10 OCCURRENCES OF CONTAMINATION. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE'S CONTAMINATION WITH THEIR 221270 PLATES FROM LOT 1285612.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661129 | BD BBL¿ MACCONKEY II AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 221270 | 1285612 | 10382902212703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |