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

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 AIR LEAKAGE WAS OBSERVED DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.

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 PRODUCTS ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AD NO OBVIOUS DEFECTS WERE CONFIRMED. THE GRAY PLUNGER WAS FOUND AT THE BOTTOM OF THE SYRINGE BARREL. SILICONE OIL WAS OBSERVED ON THE CANNULAS. A CONSOLE, REPRESENTING CURRENT SOFTWARE VERSIONS WAS USED TO TEST THE VISCOUS FLUID CONTROL TUBING. THE SYRINGE WAS CONNECTED TO THE ADAPTER AND COULD FULLY ENGAGE. THE SYRINGE SEATED IN THE ADAPTER AND THE CANNULA¿S SEATED ON THE SYRINGE LUER LOCK BARB FIRMLY AND SECURELY. THE LIGHT EMISSION DIODE RINGS ON THE CONSOLE TURNED GREEN AS THE GRAY CONNECTOR WAS ENGAGED TO THE CONSOLE INDICATING THE PROPER COMMUNICATION BETWEEN THE CONNECTOR AND THE CONSOLE. THE CANNULA DID NOT POP OFF DURING FUNCTIONAL TESTING. PRESSURE WAS STABLE DURING FUNCTIONAL TESTING. THE PLUNGER IN THE SYRINGE MOVED SMOOTHLY DURING OPERATION. THE ROOT CAUSE OF THE CUSTOMERS COMPLAINT COULD NOT BE ESTABLISHED SINCE THE RETURNED SAMPLE MET SPECIFICATIONS, ALL CONNECTIONS WERE FOUND TO FIT SECURELY. NO CONTRIBUTING FACTORS COULD BE IDENTIFIED THAT COULD CAUSE THE REPORTED COMPLAINT. AFTER THE INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE MET SPECIFICATIONS. THEREFORE, NO ACTION WILL BE TAKEN AT THIS TIME. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR CUSTOMER COMPLAINTS VIA THE COMPLAINT REVIEW MEETINGS AND WILL TAKE ACTION FOR ANY FUTURE OCCURRENCES AS IS DEEMED NECESSARY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED THAT AIR LEAKAGE WAS OBSERVED DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.