MalfunctionOES
MEDLINE
Received Jul 22, 2026 · Event occurred Jun 10, 2026
Report 1423395-2026-00413 · MDR key 25909671
Device
Product problems
- Detachment of Device or Device Component
Patient
93 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CONTROL SYRINGE UNSCREWS FROM THE MANIFOLD AND IT IS UNABLE TO STAY CONNECTED.
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT THE CONTROL SYRINGE UNSCREWS AND POPS OFF THE BACK OF THE MANIFOLD HALFWAY THROUGH THE PROCEDURE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF.