ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2
Received Aug 11, 2015 · Event occurred Jul 16, 2015
Report 1036844-2015-00322 · MDR key 4999154
Device
Product problems
- Difficult to Remove
- Torn Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A LOT NUMBER FROM SALES HISTORY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES "USE EXTREME CARE TO NEVER ADJUST POSITION OF THE NEEDLE WHILE CATHETER TIP IS STILL ADVANCED BEYOND TIP OF NEEDLE." IF THE CATHETER IS RETRACTED AGAINST THE NEEDLE BEVEL, IT CAN LEAD THE CATHETER TO SHEAR AS THE CUSTOMER REPORTED. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT THE SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER THROUGH THE NEEDLE COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE.
Description of Event or Problem
A CUSTOMER ALLEGES HAVING DIFFICULTY IN REMOVING THE NEEDLE AND STYLET. THE CATHETER SHEARED AND HAD TO BE RESTARTED. NO PT INJURY REPORTED. PROCEDURE - TOTAL KNEE REPLACEMENT.