BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTISEAL HVLP CUFFED ORAL/NASAL ET TUBE ID SUZE 3.5MM

    MDR report key: 8357306 · Received February 21, 2019

    Report

    Report Number
    3006061749-2018-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    January 19, 2018
    Report Date
    December 17, 2018
    Manufacturer
    FLEXICARE MEDICAL DONGGUAN LYD.
    Product Code
    BTR
    PMA / PMN Number
    K091591
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SMALL SIZE OF ET TUBE USES A VERY FINE INFLATION LINE WHICH IS BONDED USING A PVC SOLVENT. EXCESS SOLVENT CAN WEAKENED THE TUBE WALL AND REDUCE THE RESISTANCE TO SEPARATION UNDER TENSILE FORCES. PROCESS HAS BEEN CHANGED TO INTRODUCE THE END OF THE TUBE INTO A FOAM TO REMOVE EXCESS SOLVENT BEFORE BONDING. USER FACILITY REPORT (B)(4) SUBMITTED INCORRECTLY REFERS TO THE SUSPECT MEDICAL DEVICE AS SIZE ID 7.5MM. HOWEVER, IN THE EVENT DESCRIPTION THE SIZE AS 3.5MM IS STATED AS ID 3.5MM WHICH IS IN LINE WITH THE PATIENT'S AGE.

    Description of Event or Problem · 1

    EVENT: PATIENT ON VENTILATOR. DESATURATING AND SHOWING INCREASED WORK OF BREATHING. WAVEFORM ON VENTILATOR MONITOR SHOWED A LEAK. PATIENT RE-INTUBATED AND LEAK STOPPED, SATURATIONS RETURNED TO 100%. PROBLEM: ET TUBE CUFF INFLATION LINE DISSOCIATED FROM THE ET TUBE RESULTING IN CUFF DEFLATION AND LOSS OF SEAL AGAINST THE TRACHEAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150313 VENTISEAL HVLP CUFFED ORAL/NASAL ET TUBE ID SUZE 3.5MM ENDOTRACHEAL TUBE (ET TUBE) BTR FLEXICARE MEDICAL DONGGUAN LYD. 038-971-035U NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention