inforMED
MalfunctionBSK

AG CUFFILL (CMH2O)

Received Mar 30, 2026 · Event occurred Mar 15, 2026

Report 24710306 · MDR key 24710306

Device

Generic name

Cuff, Tracheal Tube, Inflatable

Model number

HSCUFF0041

Catalog number

HSCUFF0041

Patient

66 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ARRIVED BEDSIDE TO A SMALL AUDIBLE CUFF LEAK. INSPIRATORY VT [TIDAL VOLUME] WAS 430; EXP [EXPIRATORY] WAS 330. AFTER CHECKING CUFF PRESSURE MULTIPLE TIMES WITH THE AG CUFFILL SYRINGE MORE AIR WAS ESCAPING CUFF CAUSING A GREATER CUFF LEAK. INSP [INSPIRATORY] VT490 - EXP VT NOW 180. CALLED PROVIDER BEDSIDE TO INFORM A FAILED PILOT OR CUFF. ANESTHESIA WAS THEN CALLED FOR A TUBE EXCHANGE. A 6.5 ETT [ENDOTRACHEAL TUBE] WAS THEN PLACED IN AIRWAY WITH POSITIVE ETCO2 [END-TIDAL CARBON DIOXIDE] AND BREATH SOUNDS. WE INSPECTED THE FORMER AIRWAY AND ESTABLISHED THAT ETT WAS INTACT WITH NO LEAK. AFTER FURTHER INVESTIGATION WE ESTABLISHED THAT THE AG CUFFILL SYRINGE HAD FAILED TO MAINTAIN PRESSURE DUE TO A CRACK ON THE SIDE OF THE SYRINGE ALLOWING AIR TO ESCAPE.