BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 10089985 · Received May 26, 2020

    Report

    Report Number
    3014680755-2020-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 6, 2020
    Report Date
    May 14, 2020
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CAE
    UDI-DI
    00812277033700
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMS SERVICE WAS RESPONDING TO A CARDIAC ARREST CALL AND ATTEMPTED TO USE THE CURAPLEX KIT KLTSD404K TO CARE FOR THE PATIENT, BUT DISCOVERED THE CATHETER TIP OF THE SYRINGE INCLUDED TO INFLATE THE SUPRAGLOTTIC AIRWAY WAS NOT COMPATIBLE WITH THE LUER CONNECTOR OF THE AIRWAY. AS A RESULT, THE EMS SERVICE WAS FORCED TO SEEK OTHER MEASURES TO ESTABLISH AN AIRWAY FOR THE PATIENT. NO INJURIES OR DEATH WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553873 CURAPLEX KING LTS-D SUPRAGLOTTIC AIRWAY KIT CAE BOUND TREE MEDICAL, LLC KLTSD404K ASM0025699 00812277033700

    Patients

    Seq Age Sex Outcome Treatment
    1