MalfunctionBTR

RUSCH FLEXI-SET CUFFED 7.0MM

Received Jun 30, 2026 · Event occurred Jun 2, 2026

Report 8040412-2026-00099 · MDR key 25669503

Device

Generic name

Tube, Tracheal (w/wo Connector

Manufacturer

Teleflex Medical Sdn. Bhd.

Catalog number

504570

Lot number

40E25L4530

Product problems

Gas/Air Leak

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "THE CUFF AND THE PILOT BALLOON SEEM TO BE TRANSFERRING THE AIR BETWEEN EACH OTHER. THE PILOT BALLOON DOESN'T RETAIN ANY AIR, AND ETT CUFF STARTED TO DEFLATE WHILE IN PATIENT. CUSTOMER WENT A DIFFERENT DIRECTION TO COMPLETE THE PROCEDURE." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S STATUS IS REPORTED AS "FINE."