BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SOFT GUEDEL AIRWAY CLEAR PLASTIC

    MDR report key: 17297380 · Received July 11, 2023

    Report

    Report Number
    17297380
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 20, 2023
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A SIZE 10.0 ORAL AIRWAY WAS PLACED IN THE MOUTH AS A BITE BLOCK BY THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) AT THE CONCLUSION OF A GENERAL ENDOTRACHEAL ANESTHETIC. AS THE PATIENT EMERGED, HE BIT DOWN FORCIBLY CAUSING THE ORAL AIRWAY DEVICE TO MALFUNCTION. THE RED COLORED PLASTIC PIECE AT THE FRONT OF THE ORAL AIRWAY DISENGAGED FROM THE REST OF THE ORAL AIRWAY AND SHOT ~20 FEET ACROSS THE OPERATING ROOM AS A PROJECTILE. NEITHER THE RED OR CLEAR PLASTIC PIECES FRACTURED. NO ONE WAS HIT BY THE PROJECTILE. THE PIECE DID NOT TOUCH A STERILE FIELD. THE PATIENT DID NOT HAVE ANY HARM AND WAS EXTUBATED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108161 RUSCH SOFT GUEDEL AIRWAY CLEAR PLASTIC AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY CAE TELEFLEX INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA Male