BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDI OROGASTRIC CATHETER

    MDR report key: 3845947 · Received May 29, 2014

    Report

    Report Number
    MW5036415
    Event Type
    Other
    Date Received
    May 29, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS ON NAVA VENTILATION, REQUIRING AN EDI OROGASTRIC CATHETER (66-85-775) RATHER THAN THE TYPICAL OG FEEDING TUBE (KANGAROO BRAND FROM COVIDIEN). THE KANGAROO FEEDING SYSTEM IS COLOR CODED (PURPLE) AND HAS CONNECTIONS THAT PREVENT IT FROM BEING CONNECTED TO AN IV SYSTEM. DUE TO THE EDI CATHETER NECESSITY, THE KANGAROO FEEDING TUBE WAS NOT IN PLACE. THE EDI CATHETER HAS NO COLOR SIGNIFICANCE AS IT RELATES TO FEEDING. ADDITIONALLY, THE BABY HAD A CLOSED BALLARD SUCTION ((B)(4)) IN LINE FOR ENDOTRACHEAL SUCTIONING. THE BALLARD SUCTION SET-UP HAS AN ATTACHED PORT TO CONNECT NS LAVAGE TO SO THE TUBING CAN BE CLEARED AFTER SUCTIONING PULMONARY SECRETIONS. THESE ARE COLOR-CODED FOR SIZE ONLY. SINCE THE BABY NEEDED NAVA AND THUS THE EDI TUBE, THE COLOR-CODED SAFETY FEATURE OF THE KANGAROO SYSTEM WAS NOT IN PLACE. LATE IN THE SHIFT, A FEEDING WAS ATTACHED TO THE LAVAGE PORT OF THE BALLARD SUCTION RATHER THAN TO THE EDI CATHETER. IN SPEAKING WITH THE NURSE, SHE NOTED THAT THE INFANT REQUIRED FREQUENT SUCTIONING THROUGHOUT THE SHIFT AND SHE ATTACHED THE FEEDING TO THE LAVAGE PORT USING HABITUAL BEHAVIOR. THE ERROR WAS RECOGNIZED WHEN APPROX 2ML OF FEEDING HAD INFUSED. THE INFANT WAS EXTUBATED THE FOLLOWING DAY WITH NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317452 EDI OROGASTRIC CATHETER NUTRITIONAL DELIVERY KNT COVIDIEN
    317453 BALLARD SUCTION SUCTION BSY BALLARD 4635897

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR