BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDDYPORT NIV MAINTENANCE KIT

    MDR report key: 12672343 · Received October 20, 2021

    Report

    Report Number
    MW5104802
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    August 29, 2021
    Report Date
    October 18, 2021
    Manufacturer
    SMD MANUFACTURING LLC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ORALLY SUCTIONING THE PATIENT WITH ONE OF THE REDDYPORT NIV MAINTENANCE KIT DEVICES, A PLASTIC PIECE OF THE DEVICE BROKE OFF INTO THE PATIENT'S MOUTH. THE PLASTIC PIECE GOT STUCK DEEP INTO THE PATIENTS MOUTH. IT REQUIRED ONE NURSE TO HOLD OPEN THE PATIENT'S MOUTH WHILE ANOTHER NURSE MANUALLY REMOVED THE PIECE WITH THEIR FINGERS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566922 REDDYPORT NIV MAINTENANCE KIT CATHETER AND TIP, SUCTION JOL SMD MANUFACTURING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention