InjuryPIF

EDI CATHETER ENFIT 6FR/49 CM, 5PCS

Received Jun 16, 2026 · Event occurred May 26, 2026

Report 3013876692-2026-00079 · MDR key 25519016

Device

Generic name

Gastrointestinal Tubes With Enteral Specific Connectors

Manufacturer

Maquet Critical Care Ab

Model number

6883898

Lot number

3000515175

Product problems

Insufficient Device Problem Information

Patient

NA · Unknown

Bowel Perforation

Narrative

Description of Event or Problem

IT WAS REPORTED THAT WHILE THE PATIENT WAS RECEIVING VENTILATION IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE WITH AN EDI CATHETER IN PLACE, A GASTRIC PERFORATION OCCURRED. SURGICAL INTERVENTION WAS REQUIRED. THE FINAL PATIENT OUTCOME WAS REPORTED AS NO HARM. MANUFACTURER¿S REF #: (B)(4).