VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER SPECIFIC TO THIS EVENT; THEREFORE, DEVICE HISTORY RECORD AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETURN THE VISCOUS FLUID CONTROL (VFC) TUBING ASSEMBLY AND THEREFORE A FULL EVALUATION COULD NOT BE PERFORMED TO CONFIRM THE EVENT. IT IS IMPORTANT TO REMIND THE CUSTOMER TO RETURN ALL PARTS ASSOCIATED WITH THE EVENT FOR A FULL INVESTIGATION. THE SMALL PARTS TRAY AND VFC 10 MILLILITER (ML) SYRINGE WAS RETURNED AND TESTED WITH LAB STOCK TUBING MANIFOLD AND WAS FOUND TO BE CONFORMING TO SPECIFICATIONS. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED WITH THE VFC PARTS RETURNED FOR INVESTIGATION. AFTER INVESTIGATION OF THIS COMPLAINT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT OIL DID NOT COME OUT WHEN INJECTED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.