BD BBL¿ CHROMAGAR® MRSA II
Received Sep 9, 2025 · Event occurred Aug 14, 2025
Report 1119779-2025-04958 · MDR key 23003289
Device
Generic name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
215228
Lot number
5167795
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING ONE BD BBL¿ CHROMAGAR® MRSA II, THE PLATE DID NOT SHOW ANY GROWTH FOR PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: DURING MANUFACTURING OF MATERIAL 215228, 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 5167795 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. PLATE CHROMAGAR MRSA II IS STABILITY TESTED BIENNIALLY FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS. ALL PERFORMANCE TESTING ON THIS BATCH WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO OTHER COMPLAINTS HAVE BEEN TAKEN FOR PERFORMANCE ON BATCH 5167795. THERE WERE NO RETENTION SAMPLES AVAILABLE TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THERE WERE NO PHOTOS OR RETURNS PROVIDED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
Description of Event or Problem
IT WAS REPORTED WHILE USING ONE BD BBL¿ CHROMAGAR® MRSA II, THE PLATE DID NOT SHOW ANY GROWTH FOR PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.