ARROW CONTINUOUS NERVE BLOCK KIT
Received Nov 21, 2014 · Event occurred Nov 10, 2014
Report 1036844-2014-00457 · MDR key 4293245
Device
Product problems
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGES THAT AFTER SUCCESSFUL INSERTION AND AFTER THE PT LEFT THE FACILITY THE CATHETER WAS RIPPED/YANKED OUT OF THE INTERSCALENE BLOCK. IT IS UNK HOW THE EVENT OCCURRED AT THIS TIME. PER THE DOCTOR, UPON INSPECTION OF THE CATHETER, THE DISTAL TIP IS MISSING AND POSSIBLY INSIDE THE PT. THE PT HAD AN X-RAY TAKEN TO VERIFY. PER SALES REP., THE X-RAY CAME BACK NEGATIVE FOR THE RETAINED DEVICE.
Additional Manufacturer Narrative
(B)(4). A VISUAL AND PHOTO INSPECTION WAS CONDUCTED. THE DISTAL TIP OF CATHETER CANNOT BE SEEN FROM PHOTO. VISUAL EXAMINE OF DEVICE REVEALED USED CATHETER WITH ADHESIVE RESIDUE PRESENT. THE CENTIMETER MARKERS OF CATHETER ARE WORN AND HAVE NO EXPOSED COIL AT PROXIMAL OR DISTAL END. THE RETURNED CATHETER APPEARS SHORTER THAN THE LAB INVENTORY CATHETER, INDICATING AT LEAST 3.131 CM OF CATHETER IS MISSING. THE RETURNED CATHETER APPEARS STRETCHED AT THE DISTAL END. NO LOT NUMBER PROVIDED. A DHR WAS PERFORMED ON REP LOT NUMBER AND NO RELEVANT FINDINGS WERE OBSERVED. THE IFU STATES TO NEVER TUG OR PULL QUICKLY ON THE CATHETER DURING REMOVAL SO AS TO MINIMIZE THE RISK OF CATHETER BREAKAGE. A CORRECTIVE ACTION IS NOT REQUIRED, AT THIS TIME, AS THE DAMAGE OBSERVED AND THE INFO PROVIDED INDICATES THAT THE USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED COMPLAINT OF A MISSING DISTAL TIP WAS CONFIRMED BASED ON THE CONDITION OF THE SAMPLE AND INFO PROVIDED. THE USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.