Additional Manufacturer Narrative · 1
SMITHS MEDICAL INT'L WAS NOTIFIED OF THIS EVENT ON 6/29/06. HOWEVER, SMITHS MEDICAL ASD, INC. WAS NOT NOTIFIED OF THIS EVENT UNTIL 1/25/07. THIS CATALOG NUMBER IS NOT SOLD IN THE US, HOWEVER, SIMILAR PRODUCT IS. RESULTS EVALUATIONS CODES: INVESTIGATION: THE RETURNED SAMPLE WAS VISUALLY INSPECTED. IT WAS OBSERVED THAT THE TUBE WAS SEPARATED FROM THE FLANGE AT THE JUNCTION OF THE TUBE AND FLANGE. THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT CODE AGAINST SALES OF PRODUCTS ANNUALLY. ROOT CAUSE: THE FOLLOWING POSSIBLE ROOT CAUSES WERE IDENTIFIED: SHORT CYCLE - THE WELDING CYCLE HAS BEEN STOPPED PREMATURELY BY THE OPERATOR. SET-UP SAMPLE NOT DISCARDED - THE SAMPLE WAS PRODUCED DURING SET-UP OF THE EQUIPMENT AND MAY NOT HAVE BEEN DISCARDED IN LINE WITH THE MANUFACTURING PROCEDURES. FAILURE TO DETECT THE FAULT DURING TACTILE INSPECTION. ACTION TAKEN: THE WELDING PROCEDURE HAS BEEN REVISED TO STATE THAT RE-WELDING OF TUBES MUST NOT OCCUR. THE FITTING OF AN INTERLOCK TO THE WELDER TO HALF PRODUCTION AND SETTER INTERVENTION TO RESTART. THE FITTING OF A LOCKABLE GUARD TO THE WELDING MACHINE TO PREVENT UNAUTHORIZED SETTINGS ADJUSTMENTS. IMPLEMENTATION OF AN ADDTIONAL DESTRUCTIVE PULL TEST ON SAMPLES TAKEN DURING EACH PRODUCTION RUN. IMPLEMENTATION OF ADDITIONAL PROCESS MONITORING SPECIFIC TO THE WELDING OPERATION. RETRAINING OF OPERATOR RETRAINING ON THE FLANGE WELDING MACHINE AND THE SUBSEQUENT INSPECTION PROCEDURES. WITHOUT KNOWING THE LOT NUMBER INVOLVED IT IS POSSIBLE THAT THEY WERE MADE PRIOR TO THE IMPLEMENTATION OF THE ABOVE CORRECTIVE ACTIONS.