inforMED
InjuryPIF

EDI CATHETER ENFIT 6FR/50 CM, 5PCS

Received Jul 20, 2026 · Event occurred Jul 10, 2026

Report 8010042-2026-0000986 · MDR key 25872124

Device

Generic name

Gastrointestinal Tubes With Enteral Specific Connectors

Catalog number

6685777

Lot number

3000520870

Product problems

  • Fracture

Patient

1 MO · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AN EDI CATHETER USED FOR NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) TREATMENT BROKE IN THE PATIENT¿S STOMACH. A RESIDUE OF THE EDI CATHETER REMAINS IN THE ABDOMEN, AND A PROCEDURE IS PLANNED TO REMOVE IT. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).