BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX 51161 NASOPHARYNGEAL AIRWAY LATEX-FREE

    MDR report key: 8759793 · Received July 2, 2019

    Report

    Report Number
    MW5087837
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    December 27, 2018
    Report Date
    June 28, 2019
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTQ
    UDI-DI
    00817617025780
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    I MANAGE QUALITY ASSURANCE FOR THE FIRE DEPARTMENT BASED PARAMEDIC UNITS IN (B)(6). WE HAD A NASOPHARYNGEAL AIRWAY BACKWARDS INTO THE OROPHARYNGEAL SPACE. THE EMS CREW PLACED TWO NASOPHARYNGEAL AIRWAYS ON A CARDIAC ARREST PATIENT (ROUTINE), AND WHEN THEY LATER PLACED A KING AIRWAY, THEY WERE UNABLE TO GET A DEFINITIVE ETC02 READING. THEY THEN PULLED THE KING AND DISCOVERED THE NPA HAD DISPLACED BACKWARD AND WAS BLOCKING THE KING FROM SEALING PROPERLY. THUS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE HOSPITAL CONTACTED THE FIRE DEPARTMENT PREVIOUSLY TO REPORT A SIMILAR INCIDENT ON (B)(6) 2018. (NOTE--THE CASE WAS 8 MONTHS PRIOR AND WE WERE UNAWARE UNTIL THE OTHER CASE WAS REVIEWED). THE ICU STAFF WAS UNABLE TO CLEAR THE PATIENTS GURGLING RESPIRATIONS THROUGH SUCTIONING, AND DISCOVERED A SIMILARLY DISPLACED NPA 10 DAYS AFTER ADMISSION. UPON INVESTIGATION, IT WAS NOTED THAT THE CLEAR CURAPLEX NPAS THAT WE WERE GETTING THROUGH BOUND TREE HAVE A MUCH SMALLER FLANGE THAN PREVIOUS SUPPLIERS. WE ARE PULLING THE CURAPLEX NPAS FROM SERVICE TO THE EXTENT THAT WE HAVE OTHER OPTIONS AVAILABLE. IT IS OUR OPINION THAT THE DISPLACED NPA COULD CONCEIVABLY ENTIRELY OBSTRUCT THE PATIENT'S AIRWAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545940 CURAPLEX 51161 NASOPHARYNGEAL AIRWAY LATEX-FREE AIRWAY, NASOPHARYNGEAL BTQ BOUND TREE MEDICAL, LLC 51154-51161 1501518 00817617025780

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention