UNIVERSAL VISCOUS FLUID CONTROL PACK

Description of Event or Problem

THE USER FACILITY IN SWITZERLAND REPORTED THAT THE CONNECTION TUBE CAME LOOSE SEVERAL TIMES AT THE LUER LOCK CONNECTION WITH THE OXANE SYRINGE. THE SILICONE OIL WAS INJECTED INTO THE EYE WITH MANUAL SUPPORT. THE EYE COLLAPSED AND ADDITIONAL ANESTHESIA WAS REQUIRED AS THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 10 MINUTES. THE INCIDENT DID NOT PUT THE PATIENT¿S EYE INTO PERMANENT OR TEMPORARY SERIOUS DETERIORATION OF PATIENT¿S STATE OF HEALTH AS THE SURGEON STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER REPORT OF ANY RE-OPERATION OF THE EYE, EYESIGHT DETERIORATION, BLEEDING, OR RETINAL DAMAGE DESPITE THERE WAS AN EYE COLLAPSE. THE POSSIBILITY OF RETINAL AND VITREOUS HEMORRHAGE, CHOROIDAL DETACHMENT DUE TO ACUTE HYPOTONY CANNOT BE RULED OUT DUE TO HYPOTONY CAUSED BY THE LOOSE CONNECTION (ALTHOUGH NO ADVERSE EVENTS OCCURRED).

Additional Manufacturer Narrative

THE DEVICE HAS BEEN REQUESTED BUT NOT YET RETURNED. THE LOT HISTORY FOR THIS PRODUCT SHOWS NO ISSUES RELATED TO THE REPORTED COMPLAINT. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

Additional Manufacturer Narrative

ONE OPENED POUCH OF BL7600 WAS RECEIVED WITH AN INJECTION AIRLINE ASSEMBLY CONNECTED TO AN EMPTY VIAL OF OXANE SILICONE OIL, CONNECTED TO AN INFUSION LINE ASSEMBLY, AND AN UNOPENED BL7600 INNER POUCH 1 WITH ALL CONTENTS INTACT. THE VIAL OF OXANE OIL AND INFUSION LINE ASSEMBLY CONNECTED TO IT ARE NOT PART OF OUR BL7600 UNIVERSAL VIXCOUS FLUID CONTROL PACK. EVALUATION FOUND, DURING ATTACHMENT THE LUER CONNECTOR ON THE INFUSION LINE BACKS AWAY FROM THE SEATED POSITION ON THE VIAL WHEN RELEASED. TESTING FOR LEAKS OR DETACHMENT UNDER PRESSURE WAS NOT POSSIBLE AS THE PISTON IS POSITIONED AT THE END OF ITS TRAVEL INSIDE THE VIAL OCCLUDING THE PATHWAY. INNER POUCH 1 WAS OPENED AND CANNULA LUER HUB WAS ATTACHED TO THE OXANE OIL VIAL WITH THE SAME RESULTS. WHEN TIGHTENED AND RELEASED THE LUER FITTING BACKED AWAY FROM THE SEATED POSITION. VISUAL INSPECTION OF THE THREADS ON THE VIAL DO NOT APPEAR DAMAGED. CONFORMANCE OF VIAL CANNOT BE DETERMINED AS THIS NOT A PRODUCT OF SYNERGETICS. THE ISSUE IS WITH THE OXANE OIL VIAL WHICH IS AN ACCESSORY NOT MANUFACTURED BY US AND NOT PART OF OUR BL7600 PACK. IT WAS OBSERVED THAT OIL WAS PRESENT ON THE THREADS OF THE SYRINGE AND ON THE MATING THREADS OF THE INFUSION LINE. WHEN CLEANED AND MATED, THE TWO COMPONENTS APPEAR TO HOLD TIGHT AND NOT BACK AWAY FROM SEATED POSITION.

Additional Manufacturer Narrative

D. 4. UDI# (B)(4).