BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL)
Report
- Report Number
- 1119779-2023-00017
- Event Type
- Malfunction
- Date Received
- January 11, 2023
- Date of Event
- January 5, 2023
- Report Date
- February 28, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JSI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: 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 REVIEW FOR BATCH 2305727 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 2305727. NO RETENTION SAMPLES FOR THIS BATCH WERE AVAILABLE FOR INVESTIGATION. THREE (3) PHOTOS WERE RECEIVED FOR INVESTIGATION. PHOTO ONE SHOWS TWO PLATES, ONE WITH VISIBLE GROWTH (LOT 2305727 TIMESTAMP 2208) AND ANOTHER WITH NO VISIBLE DEFECTS (LOT 2305827 TIMESTAMP 2208). PHOTO TWO SHOWS PLATE IN SLEEVE (LOT 2305727 TIMESTAMP 2208) WITH VISIBLE LARGE FURRY GROWTH. PHOTO THREE SHOWS ONE SLEEVE OF PLATES (LOT 2305727 REF 221278) WITH VISIBLE FURRY GROWTHS THROUGH SLEEVE. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED. BD HAS IDENTIFIED A CONTAMINATION TREND FOR THIS PRODUCT AND THE INVESTIGATION FOUND OPPORTUNITIES FOR BIOBURDEN REDUCTION IN THE MANUFACTURING PROCESS.
COMMON DEVICE NAME:CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL. 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: UPON RECEIPT FOR QUALITY TESTING, CONTAMINATION DISCOVERED ON PRODUCT 221278 LOT 2305727 - PLATE SABOURAUD DEXTROSE AGAR.
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: UPON RECEIPT FOR QUALITY TESTING, CONTAMINATION DISCOVERED ON PRODUCT 221278 LOT 2305727 - PLATE SABOURAUD DEXTROSE AGAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 908599 | BD BBL¿ SABOURAUD DEXTROSE AGAR (DEEP FILL) | SEE H.10 | JSI | BECTON, DICKINSON & CO. (SPARKS) | 2305727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |