BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 20902332 · Received December 11, 2024

    Report

    Report Number
    20902332
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 15, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEOSTAT WAS CALLED AND NEONATAL NURSE PRACTITIONER (NNP) NEEDED TO VIEW ENDOTRACHEAL TUBE (ETT) WITH LARYNGOSCOPE TO CONFIRM PLACEMENT. THE 00 BLADE WAS INSERTED INTO THE MOUTH, BUT THE LIGHT WAS EXTREMELY DIM AND WAS UNABLE TO BE USED SO HAD TO UPSIZE TO AN INAPPROPRIATE BLADE SIZE OF SIZE 0 UNTIL NEW BOX COULD BE GRABBED. UPON INSPECTION OF THE 00 BLADE THE LIGHT BULB HARDLY LIT UP AT ALL A SECOND TIME WHEN REOPENED. DATE OF MANUFACTURE: MAR 2020, USE BY DATE: MAR 2025, BATCH CODE: 200505J0325, BAR CODE: ()B()4, ITEM: 301-LED-100M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570235 CURAPLEX LARYNGOSCOPE, RIGID CCW BOUND TREE MEDICAL, LLC 301-LED-100M 200505J0325

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Other