BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDI CATHETER ENFIT 6FR/49 CM, 5PCS

    MDR report key: 21855253 · Received April 17, 2025

    Report

    Report Number
    8010042-2025-0000582
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 15, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004606
    PMA / PMN Number
    K153688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE EVALUATION IS BASED ON THE INFORMATION COLLECTED TO DATE AND THE INVESTIGATION OF THE RETURNED EDI CATHETER. VISUAL INSPECTION FOUND AN INCISION IN THE INSULATION BETWEEN THE 14 AND 15 CM MARKINGS FROM THE EDI CATHETER¿S TIP. THE EDI CATHETER WAS REPORTEDLY MARKED AT 15.5 CM WHERE A PIECE OF TAPE WAS ALSO ATTACHED. THIS LIKELY REFERS TO THE RECOMMENDED NEX (NOSE-EAR-XIPHOID) MEASUREMENT. IF THIS IS THE CASE, THE HOLE WOULD HAVE BEEN WITHIN THE ESOPHAGEAL PORTION. WATER WAS FLUSHED THROUGH THE EDI CATHETER AND WAS LEAKING OUT BETWEEN THE 14 AND 15 CM MARKINGS. THE ELECTRODE ARRAY OF TEN BIPOLAR ELECTRODES WAS MEASURED, AND ALL TEN MEASURING POINTS WERE WITHIN SPECIFICATION. THE EDI CATHETER HAS BEEN ABLE TO RECORD DIAPHRAGM ELECTRICAL ACTIVITY AS INTENDED WHEN PLACED IN THE ESOPHAGUS AT THE LEVEL OF THE DIAPHRAGM. THE SHAPE OF THE INCISION SUGGESTS THAT IT WAS CUT WITH A SHARP INSTRUMENT. DURING MANUFACTURING, LEAKAGE TESTS ARE CONDUCTED BEFORE THE FEEDING HOLES ARE PUNCHED, AND A FINAL VISUAL INSPECTION IS PERFORMED. ANY HOLES OR DAMAGE SHOULD HAVE BEEN DETECTED AT THAT STAGE. NORMALLY, THE EDI CATHETER IS A CLOSED SYSTEM, EITHER CONNECTED TO A FEEDING SYRINGE/PUMP OR CAPPED WHEN THERE IS NO FEEDING. THIS PREVENTS UNWANTED ENTRY OF AIR OR LEAKAGE OF STOMACH CONTENTS. HOWEVER, A HOLE IN THE EDI CATHETER MAY LEAD TO AIR CAN ENTER THROUGH THAT HOLE IF A PRESSURE GRADIENT FAVOURING AIR ENTRY, SUCH AS DURING FEEDING OR SUCTIONING. THE CONCLUSION IS THAT THERE IS NO EVIDENCE OF MALFUNCTION OR MANUFACTURING ISSUE WITH THE EDI CATHETER. THERE ARE NO INDICATIONS THAT THE EDI CATHETER DID NOT PROVIDE THERAPY DURING ITS USAGE AND MANUFACTURING RECORDS SHOWED THAT ALL PARAMETERS WERE WITHIN THE SPECIFIED LIMITS. HOWEVER, THE INCISION IN THE EDI CATHETER MAY HAVE ALLOWED AIR TO ENTER THE PATIENT¿S STOMACH. HOW THE INCISION OCCURRED HAS NOT BEEN CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) TREATMENT, AIR ENTERED PATIENT¿S STOMACH. UPON VISUAL EXAMINATION, A SMALL HOLE WAS NOTED IN THE EDI CATHETER. THERE WAS NO INDICATION OF HARM TO THE PATIENT. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787469 EDI CATHETER ENFIT 6FR/49 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883898 UNKNOWN 17325710004606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown