ARROW CONTINUOUS NERVE BLOCK KIT
Received Mar 9, 2015 · Event occurred Jan 13, 2015
Report 1036844-2015-00054 · MDR key 4602845
Device
Product problems
- Physical Resistance
- Difficult to Advance
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE CATHETER WAS HARD TO THREAD. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Additional Manufacturer Narrative
QN#(B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE AND THE EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE RETURNED SAMPLE FUNCTIONED PROPERLY AFTER BIOLOGICAL MATERIAL WAS REMOVED FROM THE NEEDLE. THE CONDITION OF THE SAMPLE RETURNED INDICATES THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED COMPLAINT OF DIFFICULTY THREADING AND REMOVING THE CATHETER FROM THE EPIDURAL NEEDLE WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CATHETER COULD BE THREADED THROUGH THE EPIDURAL NEEDLE. HOWEVER, DUE TO EXCESSIVE DRIED BIOLOGICAL MATERIAL IN THE NEEDLE CANNULA, RESISTANCE WAS MET. AFTER SOME OF THE BIOLOGICAL MATERIAL WAS REMOVED FROM THE NEEDLE CANNULA, THE CATHETER COULD BE THREAD WITH LESS RESISTANCE AND THE COMPONENTS PASSED A FUNCTIONAL DRAG TEST. THE ID OF THE NEEDLE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE AND CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE CONDITION OF THE SAMPLE RECEIVED AND THE INFORMATION PROVIDED, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.