MalfunctionOGJ
ARROW CONTINUOUS NERVE BLOCK KIT
Received Mar 12, 2014 · Event occurred Feb 1, 2014
Report 1036844-2014-00078 · MDR key 3938099
Device
Generic name
Anesthesia Conduction Kit
Manufacturer
Arrow Intl., Inc.Catalog number
AB-19608-KS
Lot number
23F13J104
Product problems
- Material Separation
- Unraveled Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CATHETER STARTED TO UNRAVEL AND SHEAR AS IT BEGAN TO BE USED. THE CUSTOMER WAS DISCONTINUED AND A NEW CATHETER WAS USED SUCCESSFULLY. NO REPORT OF A PATIENT INJURY OR HARM.