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

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A CALIBRATED CONSOLE WAS USED TO TEST THE SAMPLE. THE VISCOUS FLUID CONTROL (VFC) SAMPLE WAS FILLED WITH SILICONE OIL PER DIRECTIONS FOR USE (DFU); IN INJECTION MODE THE PLUNGER MOVED FREELY AND MET SPECIFICATIONS. EXTRACTION MODE WAS THEN SELECTED AND THE VFC COULD ASPIRATE SILICONE OIL INTO THE BARREL OF THE SYRINGE; NO ANOMALIES WERE OBSERVED DURING THIS STEP. PRESSURE WAS STABLE DURING FUNCTIONAL TESTING. THE PLUNGER IN THE SYRINGE MOVED SMOOTHLY DURING OPERATION. ADDITIONALLY, ALL CONNECTIONS WERE FOUND TO FIT SECURELY. WE WERE UNABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE DURING LABORATORY EVALUATION. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND LOT. 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 HEALTHCARE PROFESSIONAL REPORTED THAT THE NO VACUUM DURING SURGERY. THE PROCEDURE DETAILS WERE UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.