BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTORM CURAPLEX

    MDR report key: 9139265 · Received October 1, 2019

    Report

    Report Number
    9139265
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 23, 2019
    Manufacturer
    SARNOVA HC, LLC
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CURAPLEX NASOPHARYNGEAL TUBE WAS PLACED BY EMS WHEN THEY FOUND THE PATIENT UNRESPONSIVE AND WITH A LARGE AMOUNT OF VOMIT ON SELF. THE PATIENT RECEIVED O2 VIA FACEMASK DURING TRANSPORT. DURING TRANSPORT THE NASOPHARYNGEAL TUBE MIGRATED BACK INTO THE NASAL PASSAGE AND WAS NO LONGER VISIBLE AT THE EXTERNAL NARE. THE PLACEMENT OF THE NASOPHARYNGEAL TUBE WAS NOT DOCUMENTED IN THE EMS DOCUMENTATION, NOR WAS IT REPORTED TO THE ED STAFF UPON ARRIVAL TO THE HOSPITAL. BASED ON FINDINGS FROM THE INVESTIGATION, THE EMS STAFF SAID THEY DID INSERT THE TUBE BUT DID NOT DOCUMENT IT. THE PATIENT WAS INTUBATED UPON ARRIVAL TO THE ED, BUT THE NASOPHARYNGEAL TUBE WAS NOT VISIBLE AT THE TIME, SO THE ED STAFF WERE UNAWARE OF ITS PRESENCE. TEN DAYS AFTER ADMISSION, THE PATIENT HAD A COUGHING FIT AT WHICH TIME THE NASOPHARYNGEAL TUBE WAS EXPELLED THROUGH THE MOUTH. IT IS NOTED THAT THE END OF THIS TUBE HAS MINIMAL FLARE AS COMPARTED WITH OTHER LIKE TUBES - THE FLARED END IS WHAT HELPS TO PREVENT MIGRATION OF THE TUBE PAST THE PATIENT NARES. MINIMAL FLARE ON THE END OF THIS DEVICE MAY HAVE CONTRIBUTED TO THE TUBE'S MIGRATION WITHOUT NOTICE OF STAFF (POSSIBLE DESIGN ISSUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933382 MEDSTORM CURAPLEX AIRWAY, NASOPHARYNGEAL BTQ SARNOVA HC, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA