BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX NASAL SOFT SEAL CUFFED TRACHEAL TUBE

    MDR report key: 21496522 · Received February 28, 2025

    Report

    Report Number
    3012307300-2025-02353
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    November 1, 2023
    Report Date
    February 28, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    BTR
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE IS UNKNOWN, AN APPROXIMATE DATE WAS USED. IF MORE INFORMATION ON THE DATE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERSON WAS FOUND FLOATING IN THE SEA AND RESCUED IN A STATE OF CARDIOPULMONARY ARREST. THE PARAMEDICS PERFORMED INTUBATION TO DELIVER OXYGEN. AFTER ARRIVING AT THE HOSPITAL, IT WAS FOUND THAT THE TUBE HAD ENTERED THE ESOPHAGUS INSTEAD OF THE TRACHEA AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. THE REPORTER STATED, DURING THE INTUBATION, THE PARAMEDIC ONLY CHECKED THE PATIENT WITH A STETHOSCOPE AFTER INTUBATION BUT DID NOT CHECK WITH ANY OTHER INSTRUMENTS. IT WAS ADDITIONALLY REPORTED THAT THE DOCTOR STATED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE TUBE NOT BEING IN THE TRACHEA. MEDICAL REVIEW FOLLOWS: AN 84-YEAR-OLD MAN WHO WAS FLOATING IN THE SEA WAS RESCUED IN A STATE OF CARDIOPULMONARY ARREST, AND PARAMEDICS PERFORMED TRACHEAL INTUBATION TO DELIVER OXYGEN. LATER, IT WAS FOUND THAT IT HAD ENTERED THE ESOPHAGUS INSTEAD OF THE TRACHEA AT THE HOSPITAL WHERE HE WAS TRANSPORTED. THE MAN WAS PRONOUNCED DEAD AT THE HOSPITAL. AT THAT TIME, THE PARAMEDIC ONLY CHECKED THE MAN WITH A STETHOSCOPE AFTER INSERTING THE TUBE, BUT DID NOT CHECK WITH THE PRESCRIBED MULTIPLE INSTRUMENTS. THE DOCTOR STATED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE MAN'S DEATH AND THE TUBE NOT BEING IN THE TRACHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521693 PORTEX NASAL SOFT SEAL CUFFED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITH¿S MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death