ARROW CONTINUOUS NERVE BLOCK KIT
Received Oct 6, 2014 · Event occurred Sep 12, 2014
Report 1036844-2014-00404 · MDR key 4152522
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow Intl., Inc.Catalog number
AB-19608-KS
Lot number
23F14C0764
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE STIMUCATH WITH NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE STIMUCATH WERE REVIEWED WITH NO EVIDENCE OF SUGGEST A MFG RELATED CAUSE. THE POTENTIAL CAUSE OF A CATHETER LEAK COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED AND WITHOUT A SAMPLE.
Description of Event or Problem
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CATHETER HAD A PIN HOLE SIZE LEAK LOCATED OUTSIDE OF THE PATIENT'S BODY. THE CATHETER WAS REMOVED AND THERE WAS NO PATIENT INJURY OR CONSEQUENCE.