inforMED
InjuryPIF

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

Model number

6883898

Lot 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).