ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT
Received Sep 17, 2015 · Event occurred Sep 3, 2015
Report 1036844-2015-00414 · MDR key 5084720
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow International Inc.Catalog number
ASK-20608-ROP
Lot number
23F15E0139
Product problems
- Crack
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER RETURNED ONE 20GA STIMUCATH FOR INVESTIGATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER WAS USED AS BIOLOGICAL MATERIAL COULD BE SEEN ON BOTH THE DISTAL AND PROXIMAL EXPOSED COILS. THE COILS AT THE PROXIMAL END WERE DAMAGED. THE SAFETY RIBBON WAS PRESENT AND ATTACHED, HOWEVER, THE MOST DISTAL TIP OF THE COILS WERE UNRAVELED. NO OTHER DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS ALSO PERFORMED AND NO LEAKS WERE DETECTED. THE LOT NUMBER PROVIDED BY THE CUSTOMER IS NOT A VALID LOT NUMBER FOR THE REPORTED PRODUCT CODE. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED BASED ON A LOT NUMBER (23F15G1135) FROM SALES HISTORY OF THE CUSTOMER, AND THERE WERE NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF A CATHETER LEAK WAS NOT CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED CATHETER PASSED A FUNCTIONAL LEAK TEST AND NO CRACKS WERE DETECTED ON THE CATHETER BODY. A DHR REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED SAMPLE.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT WHEN THE DOCTOR WAS INJECTING THE DRUG INTO THE CATHETER, HE NOTICED THAT THE CATHETER HAD CRACKS ALL THE WAY DOWN. THE CATHETER LEAKED ALONG THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.
Additional Manufacturer Narrative
(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT WHEN THE DOCTOR WAS INJECTING THE DRUG INTO THE CATHETER, HE NOTICED THAT THE CATHETER HAD CRACKS ALL THE WAY DOWN. THE CATHETER LEAKED ALONG THE CATHETER. NO PATIENT INJURY OR CONSEQUENCE.