MalfunctionOGE
LOCAL ANESTHESIA CUSTOM PACK_EPIDURAL KIT FOR OPERATING ROOM
Received Apr 1, 2026 · Event occurred Feb 1, 2026
Report 3012307300-2026-03133 · MDR key 24753424
Device
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED, WITH RESPECT TO EPIDURAL KIT FOR THE OPERATING ROOM, THAT UPON INJECTING THE MEDICAL LIQUID, LIQUID LEAKAGE IN ALL DIRECTIONS WAS OBSERVED. THE EVENT OCCURRED BEFORE OPENING. THERE WAS NO PATIENT INVOLVEMENT.