Additional Manufacturer Narrative · 1
SMITHS MEDICAL INT'L, LTD. WAS NOTIFIED OF THIS EVENT 4/11/06, HOWEVER, SMITHS MEDICAL ASD, INC. WAS NOT NOTIFIED OF THIS EVENT UNTIL 5/17/06. DEVICE EVAL: SMITHS MEDICAL INT'L EVAL STATES: EXAMINATION OF THE RETURNED CATHETER CONFIRMED THE CUSTOMER COMPLAINT THAT THE CATHETER WAS FOUND TO BE APPROX 62MM SHORT. IT WAS ALSO NOTED FROM EXAMINATION OF THE RETURNED SAMPLE THAT THE TIP OF THE SUSPECT CATHETER WAS CUT AS SHOWN IN THE IMAGE BELOW. A REVIEW OF OUR COMPLAINTS HISTORY HIGHLIGHTED THIS TO BE THE FIRST SUCH INSTANCE FOR THIS BATCH NUMBER. THOUGH, THERE HAVE BEEN SEVERAL COMPLAINTS OF THIS NATURE FOR THE PRODUCT RANGE, THESE ARE HISTORICAL AND DO NOT INDICATE A SYSTEMATIC FAILURE DURING MFR. A REVIEW OF THE MFG DOCUMENTATION CONFIRMED THE PRESENCE OF A 100% VISUAL CHECK FOR BOTH FORM AND LENGTH UNDER MAGNIFICATION OF THE CATHETER. IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THIS INCIDENT BUT AS ALL EPIDURAL CATHETERS UNDERGO THE ABOVE REFERENCED 100% VISUAL CHECKS, A FAULT OF THIS NATURE WOULD HAVE BEEN READILY IDENTIFIED, AND THE SUSPECT CATHETER REJECTED. HAVING VIEWED THE SUPPLIED PHOTOGRAPHS THE DAMAGE IS CONSISTENT WITH THE CATHETER HAVING BEEN DRAWN BACK THROUGH THE TUOHY NEEDLE. THERE IS A KNOWN CLINICAL RISK OF THIS OCCURRING AND AS SUCH WE HAVE INCLUDED IN OUR INSTRUCTIONS FOR USE A STATEMENT SPECIFYING THE FOLLOWING: "NEVER PULL BACK THE CATHETER THROUGH THE EPIDURAL TUOHY NEEDLE AS THIS CAN RESULT IN THE CATHETER BEING CUT AND LEFT IN THE EPIDURAL SPACE". THE INVESTIGATION HAS CONCLUDED THAT THE ROOT CAUSE OF THIS INCIDENT IS NOT CONSIDERED TO BE PRODUCT RELATED. IN VIEW OF THE ABOVE THIS COMPLAINT WILL BE CLOSED WITHOUT THE NEED FOR FURTHER CORRECTIVE ACTIONS AT THIS TIME.