NAVILYST MEDICAL
Received Mar 16, 2015 · Event occurred Jan 27, 2015
Report 1317056-2015-00075 · MDR key 4617532
Device
Generic name
High Pressure Contrast Injection Line
Manufacturer
Navilyst MedicalModel number
NACatalog number
H965920517231
Lot number
4834959
Product problems
- Air Leak
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SAMPLES HAVE BEEN RETURNED FOR EVALUATION, HOWEVER THE INVESTIGATION INTO THIS EVENT IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
HOSPITAL REPORTED VISUALIZING AIR BUBBLES WITH A NAVILYST MEDICAL HIGH PRESSURE CONTRAST INJECTION LINE WITH MALE ROTATING ADAPTOR DURING A PROCEDURE. THEY BELIEVED THAT THE AIR BUBBLES WERE COMING FROM THE ROTATING ADAPTOR. THERE WAS NO AIR INJECTION OR PT INJURY. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL, HOWEVER THEY RETURNED AN UNUSED DEVICE FROM THE SAME LOT.