MalfunctionFPK
AVANTA MANAGEMENT INJECTION
Received Nov 17, 2014 · Event occurred Nov 12, 2014
Report 4289505 · MDR key 4289505
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Medrad IncModel number
AVA 500 MPATCatalog number
AVA 500 MPAT
Lot number
*
Product problems
- Fluid/Blood Leak
Patient
*
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING SET UP OF THE MEDRAD SYSTEM (THE MULTI PATIENT KIT) WHILE "FILLING" THE SYRINGE WITH CONTRAST, IT WAS NOTICED TO BE LEAKING AT THE TUBING SITE OR THE AREA OF THE STOPCOCK. THE TUBING WAS LEAKING. STAFF REMOVED THE LEAKING TUBING AND OBTAINED NEW TUBING FROM THE SAME LOT NUMBER. THE NEW TUBING WORKED JUST FINE.