BD BBL¿ INHIBITORY MOLD AGAR DEEP FILL
Report
- Report Number
- 1119779-2026-00093
- Event Type
- Malfunction
- Date Received
- February 4, 2026
- Date of Event
- January 29, 2026
- Report Date
- February 17, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- JSJ
- UDI-DI
- 10382902981913
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DURING MANUFACTURING OF MATERIAL 298191, 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 DIAGNOSTIC SOLUTIONS DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD DIAGNOSTIC SOLUTIONS MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THE BATCH HISTORY RECORD REVIEW FOR BATCH 5188344 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 DIAGNOSTIC SOLUTIONS 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 5188344. RETENTION SAMPLES, RETURN SAMPLES, AND PHOTOS WERE NOT AVAILABLE FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION FOR BATCH 5188344. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD DIAGNOSTIC SOLUTIONS WILL CONTINUE TO TREND COMPLAINTS FOR DEFECTS.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ INHIBITORY MOLD AGAR DEEP FILL PLATE, THERE WAS VISIBLE FUNGAL GROWTH ON THE PLATE. AS THE FUNGAL CONTAMINATION WAS IMMEDIATELY NOTICED AFTER INCUBATION, NO PATIENT RESULTS WERE REPORTED. THE FUNGAL GROWTH WAS LATER IDENTIFIED AS PENICILLIUM SPECIES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 29 OF 34.
IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ INHIBITORY MOLD AGAR DEEP FILL PLATE, THERE WAS VISIBLE FUNGAL GROWTH ON THE PLATE. AS THE FUNGAL CONTAMINATION WAS IMMEDIATELY NOTICED AFTER INCUBATION, NO PATIENT RESULTS WERE REPORTED. THE FUNGAL GROWTH WAS LATER IDENTIFIED AS PENICILLIUM SPECIES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 29 OF 34.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325339 | BD BBL¿ INHIBITORY MOLD AGAR DEEP FILL | CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL | JSJ | BECTON DICKINSON & CO. (SPARKS) | 5188344 | 10382902981913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |