ARROW EPIDURAL CATHETERIZATION KIT NRFIT

Description of Event or Problem

IT WAS REPORTED THAT: "THERE WAS NO RESISTANCE WHEN THE CATHETER WAS REMOVED, HOWEVER, THE COIL WAS FOUND PROTRUDED ABOUT 30CM FROM THE CATHETER TIP AFTER REMOVAL. (ACCORDING TO THE USER, HE/SHE FELT DIFFICULTY WHEN INJECTING THE MEDICAL AGENT INTO THE CATHETER AND HAD TO PUT A PRESSURE BY HAND.). NO INJURY TO THE PATIENT, BUT THE USER THOUGHT THERE WAS A POSSIBILITY THAT SOME BROKEN PIECE HAD REMAINED IN THE BODY, SO THE PATIENT WAS TO UNDERGO AN MRI SCAN AT (B)(6) HOSPITAL. MRI OUTCOME SHOWED THAT NO PART OF THE STRETCHED EPIDURAL CATHETER WERE LEFT IN THE EPIDURAL SPACE. NO INJUST WAS REPORTED AND THE PATIENT WAS FINE.".

Additional Manufacturer Narrative

(B)(4). THE REPORTED COMPLAINT OF THE COIL WAS FOUND "PROTRUDED" FROM THE CATHETER TIP AFTER REMOVAL WAS CONFIRMED BASED UPON THE INVESTIGATION OF THE SAMPLE RECEIVED. THE CUSTOMER REPORTED THE COIL WAS FOUND "PROTRUDED" FROM THE CATHETER TIP AFTER REMOVAL. THE CUSTOMER RETURNED ONE FLAT FILTER NRFIT, ONE SNAPLOCK ASSEMBLY NRFIT, AND AN EPIDURAL CATHETER. THE COMPONENTS WERE RECEIVED CONNECTED. AT THE DISTAL END OF THE RETURNED EPIDURAL CATHETER, THE COIL WIRE APPEARED TO BE STRETCHED AND EXTENDED APPROXIMATELY 39.2CM BEYOND THE DISTAL TIP. THE IFU FOR THIS PRODUCT WARNS THE USER TO NEVER WITHDRAW THE CATHETER BACK AGAINST THE NEEDLE BEVEL AND NOT TO APPLY ADDITIONAL TENSION IF THE CATHETER BEGINS TO STRETCH AS THERE IS A RISK FOR SEPARATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THEREFORE, BASED UPON THE CONDITION OF THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "THERE WAS NO RESISTANCE WHEN THE CATHETER WAS REMOVED, HOWEVER, THE COIL WAS FOUND PROTRUDED ABOUT 30CM FROM THE CATHETER TIP AFTER REMOVAL. (ACCORDING TO THE USER, HE/SHE FELT DIFFICULTY WHEN INJECTING THE MEDICAL AGENT INTO THE CATHETER AND HAD TO PUT A PRESSURE BY HAND). NO INJURY TO THE PATIENT, BUT THE USER THOUGHT THERE WAS A POSSIBILITY THAT SOME BROKEN PIECE HAD REMAINED IN THE BODY, SO THE PATIENT WAS TO UNDERGO AN MRI SCAN AT THE UNIVERSITY HOSPITAL. MRI OUTCOME SHOWED THAT NO PART OF THE STRETCHED EPIDURAL CATHETER WERE LEFT IN THE EPIDURAL SPACE. NO INJUST WAS REPORTED AND THE PATIENT WAS FINE."