BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AG CUFFILL (CMH2O)

    MDR report key: 24710306 · Received March 30, 2026

    Report

    Report Number
    24710306
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 15, 2026
    Report Date
    March 24, 2026
    Manufacturer
    HOSPITECH RESPIRATION LTD
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234624 AG CUFFILL (CMH2O) CUFF, TRACHEAL TUBE, INFLATABLE BSK HOSPITECH RESPIRATION LTD HSCUFF0041

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other