BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
Report
- Report Number
- 1119779-2022-01553
- Event Type
- Malfunction
- Date Received
- December 27, 2022
- Date of Event
- May 23, 2022
- Report Date
- February 1, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE CORRECTED. D4. MEDICAL DEVICE LOT#: 2104326. D4. MEDICAL DEVICE EXPIRATION DATE: 13-SEP-2022. H4: DEVICE MANUFACTURE DATE: 14-APR-2022. H6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 221278, PLATE SABOURAUD DEXTROSE AGAR 100 EA, BATCH NUMBER 2104326 AND BD COMPLAINT NUMBER (B)(4) FOR CONTAMINATION. DURING MANUFACTURING OF MATERIAL 221278, 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 2104326 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 COMPLAINT HAS BEEN TAKEN ON BATCH 2104326. RETENTION SAMPLES FROM BATCH 2104326 WERE NOT AVAILABLE FOR INVESTIGATION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO SHOWS THE SIDE OF AN UNOPENED SLEEVE OF PLATES WITH FUNGAL GROWTH VISIBLE IN THE TOP PLATE. THE OTHER PHOTO FEATURES THE SLEEVE LABEL OF A SLEEVE FROM BATCH 2104326 WITH FUNGAL GROWTH IN THE TOP PLATE VISIBLE. NO RETURN SAMPLES WERE RECEIVED FOR THIS INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS. IMPLEMENTATION OF ALL ACTIONS ARE EXPECTED TO BE COMPLETED BY JULY 2023. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED MOLD CONTAMINATION IN PRODUCT 221278 LOT 2104326.
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED MOLD CONTAMINATION IN PRODUCT 221278 LOT 2104326.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2138788 | BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) | CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL | JSI | BECTON, DICKINSON & CO. (SPARKS) | 2104326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |