BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER NEO-VERSO INF/NEO 45' SWIVEL

    MDR report key: 6576864 · Received May 18, 2017

    Report

    Report Number
    2050001-2017-00058
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 18, 2017
    Manufacturer
    AOK TOOLING LIMITED
    Product Code
    CAI
    PMA / PMN Number
    D079431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER STATED VERBALLY VIA TELEPHONE "IN AN EMERGENCY, THE CHILDS HEART RATE WAS DROPPING THEY WEREN'T RECEIVING ENOUGH OXYGEN. THEY WENT TO DISCONNECT AND THE PART BROKE OFF AT THE SWIVEL." ADDITIONAL DETAILS RECEIVED VIA EMAIL: ¿INFANT DESATURATED AND BECAME BRADYCARDIC, REQUIRING AMBU BREATHS. WHEN I ATTEMPTED TO DISCONNECT NEOLINK DEVICE FROM ETT TO APPLY AMBU BAG, THE TOP OF THE DEVICE DETACHED FROM THE BASE. THE BASE REMAINED LODGED ON THE BLUE HUB OF THE ETT, MAKING IT IMPOSSIBLE TO ATTACH AND AMBU BAG TO PROVIDE BREATHS. IT WAS SEVERAL SECONDS BEFORE I WAS ABLE TO REMOVE THE BASE OF THE NEOLINK FROM THE ETT AND PROVIDE AMBU BREATHS.¿ THE PATIENT IS STABLE AND DOES NOT SEEM TO HAVE COMPLICATIONS RELATED TO THE EVENT. THE NEOLINK HAS BEEN ON THIS PATIENTS¿ ETT FOR A LONG TIME, THEREFORE I DO NOT HAVE THE ORIGINAL PACKAGE OR LOT NUMBER. I AM CONCERNED ABOUT 2 THINGS: THE FACT THAT THIS DEVICE IS DIFFICULT TO REMOVE FROM THE ENDOTRACHEAL TUBE IN AN EMERGENCY WHEN THE PATIENT REQUIRES MANUAL VENTILATION. THE FACT THAT ONE OF THE DEVICES SEPARATED WHEN A NURSE NEEDED TO REMOVE IT FROM THE PATIENT IN AN EMERGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358023 ADAPTER NEO-VERSO INF/NEO 45' SWIVEL CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI AOK TOOLING LIMITED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention