BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDI CATHETER ENFIT

    MDR report key: 9641957 · Received January 29, 2020

    Report

    Report Number
    8010042-2020-00052
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 10, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDI CATHETER WAS NOT RETURNED BUT PICTURES WERE PROVIDED SHOWING A HOLE IN THE INSULATION IN THE INVASIVE PART AT THE 22 CM MARKING. THE EDI CATHETER WAS FIXED AT 24 CM, SO THE HOLE WAS IN THE PATIENT¿S NASAL CAVITY. LEAKAGE TESTS ARE PERFORMED DURING MANUFACTURING BEFORE THE PUNCHING OF THE FEEDING HOLES AND FINAL INSPECTION IS VISUAL. A HOLE OF THIS SIZE WOULD HAVE BEEN DETECTED DURING THE LEAKAGE TEST. THE ROOT CAUSE OF THE HOLE IN THE EDI CATHETER INSULATION HAS NOT BEEN ABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS CONNECTED TO A VENTILATOR DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, ADMINISTRATION OF MEDICATION WAS PERFORMED VIA THE EDI CATHETER (A SINGLE-USE NASOGASTRIC FEEDING TUBE WITH MEASURING ELECTRODES POSITIONED IN THE ESOPHAGUS, MEASURING THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM). THE MEDICATION CAME OUT OF THE PATIENT'S NOSE. WHEN THE EDI CATHETER WAS PULLED OUT, A HOLE WAS NOTED IN THE EDI CATHETER IN THE AREA THAT WAS IN THE PATIENT¿S NASAL CAVITY. THERE WAS NO PATIENT INJURY. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105313 EDI CATHETER ENFIT GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 8FR/50 CM

    Patients

    Seq Age Sex Outcome Treatment
    1