Additional Manufacturer Narrative · 1
SMITHS MEDICAL INTERNATIONAL WAS NOTIFIED OF THIS EVENT ON 3/22/2006. HOWEVER, SMITHS MEDICAL ASD, INC. WAS NOT NOTIFIED OF THIS EVENT UNTIL 02/01/2007. THIS CATALOG NUMBER IS NOT SOLD IN THE US, HOWEVER, SIMILAR PRODUCT IS. INVESTIGATION: THE RETURNED SAMPLE WAS VISUALLY INSPECTED. VISUAL EXAMINATION FOUND THE TUBE WAS COMPLETELY DETACHED FROM THE FLANGE WITH NO EVIDENCE OF WELD WITNESS MARKS ON THE FLANGE OR TUBE INDICATING THE DEVICE HAD NOT BEEN THROUGH THE WELDING PROCESS. A REVIEW OF THE COMPLAINTS HISTORY DATABASE HIGHLIGHTED NO OTHER COMPLAINTS OF A SIMILAR NATURE FOR THIS LOT OR PRODUCT GROUP MAKING THIS AN ISOLATED INCIDENT. A FURTHER REVIEW OF THE DEVICE HISTORY RECORDS HIGHLIGHTED NO ANOMALIES. ROOT CAUSE: IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE, BUT IT IS LIKELY THE FAULT IS THE RESULT OF THE DEVICE NOT BEING SUBJECTED TO THE WELDING PROCESS. ACTION TAKEN: RE-SPECIFICATION OF IN-PROCESS TESTING TO ENSURE POORLY WELDED FLANGES ARE DETECTED AND DISPOSED OF PRIOR TO FURTHER PROCESSING. REVISE DEVICE HISTORY RECORDS TO CONFIRM. IMPLEMENT STATISTICAL PROCESS CHARTS FOR THE WELDING PROCESS. RETRAINING OF OPERATORS TO ENSURE AN UNDERSTANDING OF THE CLINICAL CONSEQUENCES OF FAILURE TO COMPLY WITH SPECIFICATIONS AND ON THE IMPLICATION OF THE ACTIONS LISTED ABOVE.