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. 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. THE RETURNED SAMPLE WAS VISUALLY INSPECTED. THE VISCOUS FLUID CONTROL (VFC) CANNULA TIP WAS DEFORMED AT THE TIP. EXAMINATION OF THE HUB FOUND NO MAJOR MARKS OR SCRATCHES THAT WOULD BE ATTRIBUTED TO A SURGICAL INSTRUMENT. AFTER AN ANALYSIS AND BASED ON THE CONDITION OF THE SAMPLE, THE ROOT CAUSE IS POTENTIALLY RELATED TO AN ERROR DURING THE SUPPLIERS ASSEMBLY PROCESS OF THE VISCOUS FLUID CONTROL (VFC) CANNULA TIP. BASED ON THE LOCATION OF THE FRACTURE AND ROUGH EDGES ON THE CANNULA, IT IS POSSIBLE THE TIP WAS DAMAGED AS A RESULT OF A SUPPLIER MANUFACTURING RELATED ERROR. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS DETERMINED THAT NO FURTHER ACTIONS WILL BE PURSUED AT THIS TIME. THE SUPPLIER HAS BEEN MADE AWARE OF THE ISSUE. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. 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 NURSE REPORTED THAT THE OIL INJECTION NEEDLE AT THE FRONT END OF THE SILICONE OIL TUBING WAS DEFORMED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.