BD BACTO BRAIN HEART INFUSION

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BACTO BRAIN HEART INFUSION BOTTLE, THE CUSTOMER NOTICED FASTER BACTERIAL GROWTH COMPARED TO PREVIOUSLY USED BATCHES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. D4. MEDICAL DEVICE LOT#: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING ONE (1) BD BACTO BRAIN HEART INFUSION BOTTLE, THE CUSTOMER NOTICED FASTER BACTERIAL GROWTH COMPARED TO PREVIOUSLY USED BATCHES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY- THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE BRAIN HEART INFUSION 500G, CATALOG NUMBER 237500, BATCH NUMBER UNKNOWN, COMPLAINT (B)(4) FOR UNSATISFACTORY PERFORMANCE. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. A REVIEW OF THE BATCH HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO OTHER COMPLAINTS ON THIS PRODUCT. NO RETURNS OR PHOTOS WERE PROVIDED. UNABLE TO TEST RETENTIONS AS NO BATCH NUMBER WAS PROVIDED. THE CUSTOMER REPORTED THE CULTURE SPEEDS VARY BETWEEN BATCHES. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. BD WILL CONTINUE TO TREND ON PERFORMANCE COMPLAINTS AND ASSESS PRODUCT INTENDED USES AGAINST REGULATORY REQUIREMENTS.