IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN AVM, TWO VIALS OF NBCA GLUE (631400/244549 AND 631400/244521), WERE CLOUDY AFTER WITHDRAWN WITH MERRITT POLYCARBONATE SYRINGES. BOTH OF THE GLUE VIALS WERE CLEAR PRIOR TO REMOVAL INTO THE SYRINGES, AND THE SYRINGES AND NEEDLES WERE FREE OF ANY BLOOD OR LIQUIDS. BOTH WERE STORED PER LABELING INSTRUCTIONS. THE VIALS WERE PART OF A DUAL PACKAGE AND ALL THE DIFFERENT COMPONENTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INJURY REPORTED, AND NEITHER DEVICE WAS USED IN THE PATIENT.
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Patient 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 244521 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00428 AND 1058196-2012-00429. THE PRODUCT WAS RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
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Patient 1
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN AVM, TWO VIALS OF NBCA GLUE ((B)(4)) WERE CLOUDY AFTER WITHDRAWN WITH MERRITT POLYCARBONATE SYRINGES. BOTH OF THE GLUE VIALS WERE CLEAR PRIOR TO REMOVAL INTO THE SYRINGES, AND THE SYRINGES AND NEEDLES WERE FREE OF ANY BLOOD OR LIQUIDS. BOTH WERE STORED PER LABELING INSTRUCTIONS. THE VIALS WERE PART OF A DUAL PACKAGE AND ALL THE DIFFERENT COMPONENTS WILL BE RETURNED FOR ANALYSIS. THERE WAS NO PATIENT INJURY REPORTED, AND NEITHER DEVICE WAS USED IN THE PATIENT. TWO POUCHES FROM LOT 244549 INSIDE A BOX FROM A LOT 244521 WERE RECEIVED. IN THE FIRST POUCH IT WAS CONTAINED A MEDALLION MERIT SYRINGE ATTACHED TO AN NBCA LIQUID TUBE. PART OF THE GLUE WAS INSIDE THE SYRINGE AND IT WAS COMPLETELY DRIED. THE COLOR WAS CLOUDY WHITE/GRAY. IN THE SECOND POUCH IT WAS RECEIVED A MEDALLION MERIT SYRINGE WITHOUT ANY NBCA TUBE. IT CONTAINED DRIED GLUE INSIDE AND IT WAS COMPLETELY DRIED AND ALSO CLOUDY WHITE/GRAY. NO FUNCTIONAL TEST CAN BE PERFORMED SINCE THE LIQUID WAS DRIED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED EVENT OF CLOUDY GLUE WAS CONFIRMED. THE CAUSE OF THE FAILURE REPORTED ON THE DEVICE COULD NOT BE DETERMINED, HOWEVER IN THE COMPLAINT IS MENTIONED "TWO VIALS OF NBCA GLUE ((B)(4)) WERE CLOUDY AFTER WITHDRAWN WITH MERRITT POLYCARBONATE SYRINGES. BOTH OF THE GLUE VIALS" AND THE PRECAUTIONS SECTION OF THE IFU OUTLINES SAYS "DO NOT USE WITH ANY DEVICE CONTAINING POLYCARBONATE. CYANOACRYLATES CAUSE POLYMERS CONTAINING POLYCARBONATE TO DETERIORATE". IN FURTHER OUTLINES IN THE DIRECTIONS FOR USE SAYS THAT THE TRUFILL N-BCA WITH TRUFILL ETHIODIZED OIL AND, IF NECESSARY, TRUFILL TANTALUM POWDER MIXTURE SHOULD BE PREPARED USING A 1 - 10CC SYRINGE(S) MADE OF POLYETHYLENE OR POLYPROPYLENE. "CAUTION: DO NOT USE WITH SYRINGES CONTAINING POLYCARBONATE". BASED ON THE AVAILABLE INFORMATION, THE USE OF POLYCARBONATE CONTRIBUTED TO THE EVENT, AND THEREFORE THE USER SHOULD CONTACT THE SYRINGE MANUFACTURER TO VERIFY SYRINGE MATERIAL.. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT IT COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY, INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCT FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00428 AND 1058196-2012-00429.