MalfunctionFOZ
INTIMA-II
Received Jul 17, 2026 · Event occurred Jun 26, 2026
Report 3006948883-2026-00469 · MDR key 25860455
Device
Product problems
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE BLOOD DRAW, BLOOD LEAKED FROM THE CONNECTION BETWEEN THE CLEAR TUBING AND THE YELLOW PLASTIC PART. REPLACING THE INDWELLING CANNULA REQUIRED A SECOND PUNCTURE, WHICH CAUSED THE PATIENT TO BECOME ANXIOUS AND INCREASED THE RISK OF INFECTION FOR THE MEDICAL STAFF.
Additional Manufacturer Narrative
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.