BD BBL¿ EGG YOLK TELLURITE ENRICHMENT

Additional Manufacturer Narrative

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 THAT THE BOTTLE OF BD BBL¿ EGG YOLK TELLURITE ENRICHMENT HAD NO LABEL ON IT. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "IN THE LAST IMPORTATION OF THE PRODUCT IDENTIFIED WITH CATALOG NO. 212357- TELLURITE EGG YOLK SOLUTION, PACKAGE OF 6 BOTTLES EACH WITH 100 ML, ONE OF THE BOTTLES ARRIVED WITHOUT AN EXTERNAL LABEL THAT ALLOWS THE CORRECT IDENTIFICATION OF THE CONTENT AND INFORMATION ON THE PRODUCT."

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY MATERIAL 212357 IS PREPARED USING A CONCENTRATED EGG YOLK EMULSION. THE EGGS ARE CLEANED, CRACKED AND SEPARATED BY HAND. ALTHOUGH THE EGG CRACKING PROCESS IS NOT STERILE OR PERFORMED IN A STERILE ENVIRONMENT, THE PROCESS WAS DEVELOPED TO MINIMIZE BIOBURDEN IN THE EGG YOLK PROCESS. THE EMULSION IS MIXED PER STANDARD OPERATING PROCEDURE (SOP). FILLING AND CAPPING ARE PERFORMED WITHIN THE ASEPTIC PROCESSING AREA. THE MEDIA IS MANUALLY DISPENSED INTO HEAT PROCESSED BOTTLES. CAPS ARE PLACED MANUALLY ON THE BOTTLES AND HAND TIGHTENED. PRODUCT IS TORQUED BY MACHINE LABELED. BOTTLES ARE INSPISSATED USING A VALIDATED CYCLE AND THEN PACKAGED IN A SEPARATE PACKING AREA. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1301306 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. FORMULATION, LABELING, AND PACKING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1301306 (6 BOTTLES) WERE AVAILABLE FOR INSPECTION. NO DEFECTS WERE OBSERVED FROM THE RETENTION SAMPLES. ALL 6/6 RETENTION BOTTLES HAD PROPERLY AFFIXED LEGIBLE LABELS. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS ONE BOTTLE. THE BOTTLE DOES NOT HAVE A LABEL. NO PRODUCT INFORMATION IS PRESENTED IN THE PHOTO.

Description of Event or Problem

IT WAS REPORTED THAT THE BOTTLE OF BD BBL¿ EGG YOLK TELLURITE ENRICHMENT HAD NO LABEL ON IT. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "IN THE LAST IMPORTATION OF THE PRODUCT IDENTIFIED WITH CATALOG NO. 212357- TELLURITE EGG YOLK SOLUTION, PACKAGE OF 6 BOTTLES EACH WITH 100 ML, ONE OF THE BOTTLES ARRIVED WITHOUT AN EXTERNAL LABEL THAT ALLOWS THE CORRECT IDENTIFICATION OF THE CONTENT AND INFORMATION ON THE PRODUCT."

Additional Manufacturer Narrative

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 THAT THE BOTTLE OF BD (B)(6) TELLURITE ENRICHMENT HAD NO LABEL ON IT. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "IN THE LAST IMPORTATION OF THE PRODUCT IDENTIFIED WITH CATALOG NO. 212357- (B)(6) SOLUTION, PACKAGE OF 6 BOTTLES EACH WITH 100 ML, ONE OF THE BOTTLES ARRIVED WITHOUT AN EXTERNAL LABEL THAT ALLOWS THE CORRECT IDENTIFICATION OF THE CONTENT AND INFORMATION ON THE PRODUCT."