BD BBL¿ MACCONKEY II AGAR
Report
- Report Number
- 1119779-2021-01077
- Event Type
- Malfunction
- Date Received
- June 29, 2021
- Date of Event
- May 26, 2021
- Report Date
- December 2, 2021
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- UDI-DI
- 00382902212703
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-29. H6: 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 1057969 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 1057969. RETENTION SAMPLES FROM BATCH 1057969 WERE NOT AVAILABLE FOR INSPECTION. ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THE PHOTO SHOWS TWO STACKS AND SEVERAL PLATES FROM BATCH 1057969 (TIME STAMP 2032) WITH AT LEAST ONE MICROBIAL COLONY GROWING ON EACH PLATE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. IT IS NOTED THAT THE DEFECT WAS OBSERVED PRIOR TO PRODUCT EXPIRY. THIS COMPLAINT CAN BE CONFIRMED. THIS PRODUCT IS NOT STERILE. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT WHILE USING 30 BD BBL¿ MACCONKEY II AGAR CONTAMINATION WAS OBSERVED 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 CONTAMINATION "
IT WAS REPORTED THAT WHILE USING 30 BD BBL¿ MACCONKEY II AGAR CONTAMINATION WAS OBSERVED 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 CONTAMINATION. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982909 | BD BBL¿ MACCONKEY II AGAR | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 1057969 | 00382902212703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |