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 NURSE REPORTED THAT INFUSION TIP WAS FRACTURED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. THE RETURNED PRODUCT WAS VISUALLY INSPECTED AD NO OBVIOUS DEFECTS WERE CONFIRMED. THE GRAY PLUNGER WAS FOUND AT THE BOTTOM OF THE SYRINGE BARREL. THE TUBING SET, 10ML SYRINGE, CANNULA NEEDLE TIPS WERE FOUND TO BE IN GOOD CONDITION. THE CANNULA NEEDLE TIPS COULD FIT INTO 10ML SYRINGE. THE TUBING SET AND GRAY TIP PLUNGER COULD FIT INTO LAB 10ML SYRINGE. THE SYRINGE SEATED IN THE ADAPTER AND THE CANNULA¿S SEATED ON THE SYRINGE LUER LOCK BARB FIRMLY AND SECURELY. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. NO FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE WARRANTED AT THIS TIME DUE TO THE PRODUCT MEETING SPECIFICATIONS. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. THE REPORTED PRODUCT WAS NOT RECEIVED AT THE INVESTIGATION SITE FOR EVALUATION. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. NO FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE WARRANTED AT THIS TIME DUE TO THE PRODUCT NOT BEING RETURNED TO THE MANUFACTURING SITE FOR TESTING. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).