Additional Manufacturer Narrative · 1
SMITHS MEDICAL INT'L WAS NOTIFIED OF THIS EVENT ON 12/28/05. 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. EXAMINATION OF THE DAMAGED AREA SHOWED A FRACTURE AT THE POINT WHERE THE TUBE ENTERS THE FLANGE. FURTHER EXAMINATION REVEALED THAT THE TUBE WAS SECURELY WELDED TO THE FLANGE AND THE TUBE DID NOT APPEAR BRITTLE. A REVIEW OF THE COMPLAINTS HISTORY DATABASE HIGHLIGHTED NO OTHER COMPLAINTS OF A SIMILAR NATURE FOR THIS LOT NUMBER AND ONE FOR THIS PRODUCT GROUP. A FURTHER REVIEW OF THE MANUFACTURING RECORDS HIGHLIGHTED NO ANOMALIES. ROOT CAUSE: IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE, BUT POSSIBLE CAUSES ARE: DEVICE WAS REMOVED FROM IT'S MANDREL USING THE TUBE, NOT FLANGE DURING THE WELDING PROCESS CAUSING A WEAK AREA ON THE TUBE AND/OR; THE USE OF EXCESSIVE FORCE ON THE TUBE WHILST IN USE. CORRECTIVE ACTION: RETRAINING OF APPLICABLE PERSONNEL.