EDI CATHETER ENFIT 6FR/49 CM, 5PCS
Received May 29, 2026 · Event occurred May 6, 2026
Report 3013876692-2026-00072 · MDR key 25332228
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Maquet Critical Care AbModel number
6883898Lot number
3000507906
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- Bradycardia
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED FREQUENT BRADYCARDIA EPISODES AND EVENTS DURING FEEDING VIA THE EDI CATHETER. THE PATIENT WAS ASSESSED MULTIPLE TIMES FOLLOWING ADJUSTMENTS TO THE VENTILATOR SETTINGS. X-RAY EXAMINATION SHOWED THAT THE EDI CATHETER WAS CURLED/KINKED WITHIN THE OROGASTRIC CAVITY AND NOT IN THE STOMACH, DESPITE THE VENTILATOR INDICATING CORRECT POSITIONING. THE EDI CATHETER WAS REMOVED, AND A SLIGHT KINK IN THE CATHETER TUBING WAS OBSERVED. THE FINAL PATIENT OUTCOME WAS REPORTED AS NO HARM. MANUFACTURER'S REF #: (B)(4).