MalfunctionGDM
HEPARIN FLUSHING NEEDLE
Received Jan 6, 2014 · Event occurred Dec 11, 2013
Report 2523190-2013-00076 · MDR key 3695346
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS NEEDLE BROKE DURING A PROCEDURE. NO PATIENT INJURY. ON (B)(6)2013, CUSTOMER REPORTS DOCTOR WAS PERFORMING A CAROTID ENDARTERECTOMY. DEVICE SNAPPED IN 2 PIECES AT THE CONNECTION OF THE HUB AND THE NEEDLE. NO X-RAY BECAUSE THEY HAD ALL THE PARTS.