BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 18182260 · Received November 21, 2023

    Report

    Report Number
    18182260
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    September 25, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    OGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GREAT CATCH BY PEDI PA WHO WAS RANDOMLY LOOKING AT LARYNGOSCOPES WHILE TEACHING/SHOWING STAFF AND NOTICED THE MILLER 1 PACKAGE CONTAINED A SMALLER BLADE, IT WAS ACTUALLY A 0. CURAVIEW LED LARYNGOSCOPE HAND AND BLADE, MILLER SIZE 1 PACKAGE, CONTAINED A SIZE 0 BLADE. THESE ARE ONE TIME USE, PREPACKAGED NEONATAL SCOPES AND BLADES. STICKER ON PACKAGING READ: MINI MILLER BLADE SIZE ITEM 301-LED-101M BATCH CODE 190424F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687391 CURAPLEX OROTRACHEAL INTUBATION GUIDE KIT OGK BOUND TREE MEDICAL, LLC 301-LED-101M 190424F

    Patients

    Seq Age Sex Outcome Treatment
    1 Female