THE MANUFACTURING REVIEW OF THE SUBJECT LOT IDENTIFIED COMPONENT CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. HOWEVER, NO DEVIATIONS WERE INITIATED AND DURING MANUFACTURING, LINE FALLOUT LEVELS WERE UNREMARKABLE. THE SUBJECT LOT WAS CONFORMING TO ALL IN-PROCESS AND FINAL INSPECTION CRITERIA. THE PROGEL KIT CONTAINS TWO PRE-LOADED GLASS CARTRIDGES. BOTH OF WHICH ARE BOTH MANUALLY LOADED INTO THE APPLICATOR HOUSING BY THE USER. THE PLUNGER IS THEN INSERTED INTO THE OPENINGS IN THE REAR OF THE CARTRIDGES. IT WAS REPORTED THAT WHEN THE SURGEON PUSHED THE PLUNGER TO EXPEL THE PROGEL, THE VIAL CRACKED. THE IFU INSTRUCTS THE USER TO "LOAD EACH CARTRIDGE INTO THE TWIN-CHAMBERED APPLICATOR HOUSING. GENTLY PRESS THE CARTRIDGES TO SEAT THEM INTO PLACE." IN ADDITION, IT WAS NOT REPORTED WHICH GLASS CARTRIDGE HAD BROKE. WITHOUT THE SUBJECT PRODUCT OR ADDITIONAL INFORMATION, A DEFINITIVE CONCLUSION AS TO HOW THE VIAL WAS CRACKED CANNOT BE REACHED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DISCARDED BY USER FACILITY.
D
Patient 1
INFORMATION AS REPORTED BY THE DAVOL SALES REP: IT WAS REPORTED THAT DURING A VAT RIGHT UPPER AND LOWER LOBE WEDGE PROCEDURE, THE SURGEON REQUESTED 2 PROGEL KITS. THE FIRST KIT WAS OPENED, PREPARED AND USED WITHOUT ANY ISSUES. THE SECOND KIT WAS OPENED AND PREPARED, AS THE SURGEON PUSHED THE PLUNGER TO EXPEL THE PROGEL, THE VIAL CRACKED. THE SURGEON CONTINUED TO PUSH THE PROGEL OUT OF THE SYRINGE; HOWEVER, NOTED ONLY ONE COMPONENT WAS SPRAYING OUT. IT WAS UNCLEAR IF IT WAS THE ALBUMIN SIDE OR THE PEG SIDE THAT WAS SPRAYING. THE SURGEON STOPPED USE OF THE DEVICE AND RETRIEVED ANOTHER PROGEL KIT OF THE SAME LOT NUMBER FROM THE STORAGE REFRIGERATOR. NO PATIENT INJURY WAS REPORTED.