MalfunctionFOZ
INTIMA-II
Received Jul 20, 2026 · Event occurred Jun 6, 2026
Report 3006948883-2026-00474 · MDR key 25875627
Device
Product problems
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
THE PATIENT WAS ADMITTED FOR URINARY TRACT STONES. ON (B)(6) 2026, THE ASSIGNED NURSE ADMINISTERED INTRAVENOUS THERAPY AS ORDERED BY THE PHYSICIAN. WHILE VENTING THE CLOSED-SYSTEM INTRAVENOUS CATHETER, THE NURSE DISCOVERED A TEAR IN THE TUBING CAUSING FLUID LEAKAGE, RENDERING THE CATHETER UNUSABLE. THE NURSE IMMEDIATELY REPLACED THE CATHETER WITH ANOTHER ONE, AFTER WHICH THE PROCEDURE PROCEEDED NORMALLY, AND THE PATIENT SUSTAINED NO HARM.