BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX NASOPHARYNGEAL AIRWAY

    MDR report key: 7991404 · Received October 22, 2018

    Report

    Report Number
    3003674698-2018-00005
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    May 18, 2018
    Report Date
    October 22, 2018
    Manufacturer
    MEDSOURCE INTERNATIONAL, LLC
    Product Code
    BTQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, WE RECEIVED A COMPLAINT FROM THE DISTRIBUTOR OF THE PRODUCT THAT THEIR END USER HAD AN ISSUE WITH A SIZE 22 NASOPHARYNGEAL AIRWAY THAT WAS INSERTED IN THE PATIENT'S NOSTRIL. THE PRODUCT WENT INTO THE NOSE AND INTO THE TRACHEA. A TRACHEOSTOMY WAS PERFORMED AND THE PRODUCT WAS LOCATED IN THE TRACHEA JUST BEYOND THE VOCAL CORDS. IT WAS INITIALLY REPORTED THAT NO INJURIES WERE INVOLVED AND THAT THE PRODUCT FROM THEIR STOCK WAS THE FOLLOWING LOT NUMBERS: 1611011715, 1607011182, 1405010674, 1611011818, 1611011818. THESE WERE NOT MEDSOURCE INTERNATIONAL LOT NUMBERS THEREFORE THE COMPLAINT WAS CLOSED. ON SEPTEMBER 19, 2018, OUR DISTRIBUTOR INFORMED US THAT WHEN THE CUSTOMER RETURNED THEIR PRODUCT, THERE WAS PRODUCT FROM 2 DIFFERENT MANUFACTURERS/SUPPLIERS. MEDSOURCE REOPENED THE COMPLAINT AND REACHED OUT TO THE END USER. ON OCTOBER 1, 2018, MEDSOURCE WAS INFORMED BY EMAIL THAT THE PRODUCT HAD TO BE SURGICALLY REMOVED. MEDSOURCE REACHED OUT TO THE END USER FOR ADDITIONAL INFORMATION MULTIPLE TIMES AND DID NOT GET A RESPONSE UNTIL 10/15/2018 OF THE DETAILS OF THE PROCEDURE INVOLVED. SIZING INFORMATION AND PATIENT INFORMATION WERE NOT AVAILABLE. THE PRODUCT AND THE LOT NUMBER OF THE PRODUCT INVOLVED IN THE INCIDENT WERE NOT AVAILABLE, THEREFORE WE CANNOT CONFIRM IF THIS WAS MEDSOURCE PRODUCT AND COULD NOT DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WENT INTO THE NOSE AND INTO THE TRACHEA. A TRACHEOSTOMY WAS PREFORMED TO REMOVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831208 CURAPLEX NASOPHARYNGEAL AIRWAY AIRWAY, NASOPHARYNGEAL AIRWAY BTQ MEDSOURCE INTERNATIONAL, LLC 51155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other