BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR

    MDR report key: 3644824 · Received January 7, 2014

    Report

    Report Number
    2025917-2014-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER, PHOTOS WERE PROVIDED BY THE USER FACILITY. A VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED WAS PERFORMED, AND IT APPEARS THAT THE DEVICE WAS POSSIBLY TAMPERED WITH, CUT OR CAME INTO CONTACT WITH SOME SORT OF SHARP OBJECT. THE INITIAL REPORTER STATED THAT TO HIS KNOWLEDGE, THERE WERE "NO SHARP OBJECTS AND NO CUTTING." BASED ON THE FACT THAT THE MANUFACTURER NEVER RECEIVED THE ACTUAL DEVICE AND THE FACT THAT NO COMPLAINTS OF THIS NATURE REGARDING THIS DEVICE HAVE EVER BEEN BROUGHT TO THE ATTENTION OF THE MANUFACTURER, THE COMPLAINT COULD NOT BE CONFIRMED AND NO DESIGN CHANGES WERE MADE. THE CLINICAL COMPLAINT QUESTIONNAIRE COMPLETED BY THE USER FACILITY, AS WELL AS THE PHOTOS TAKEN BY THE FACILITY, ARE PROVIDED WITH THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ANY FURTHER INFORMATION REGARDING THE ISSUE BECOME AVAILABLE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DEVICE DEVELOPED A "VISIBLE CRACK WHILE ON THE PATIENT." HOSPITAL STAFF "REMOVED THE DEVICE AND REPLACED WITH ANOTHER ONE." NO HARM CAME TO THE PATIENT AS A RESULT. AS OF THE DATE OF THE MANUFACTURER BEING MADE AWARE OF THE ISSUE, THE PATIENT'S CONDITION WAS DESCRIBED, "STILL IN NICU ON LIFE SUPPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11359 NEOBAR ET TUBE HOLDER CBH NEOTECH PRODUCTS, INC. N712

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Required Intervention