BEUDAMED
    FDA Adverse Event Summary report: N

    SUCTION CATHETER KIT, 8 FR

    MDR report key: 16606 · Received October 5, 1994

    Report

    Report Number
    MW1003604
    Date Received
    October 5, 1994
    Date of Event
    September 27, 1994
    Report Date
    September 29, 1994
    Manufacturer
    SUPERIOR HEALTHCARE GROUP, INC.
    Product Code
    BSY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT USED IN THE NICU FOR SUCTIONING NEWBORN INFANTS. REPEAT OF PROBLEM EXPERIENCED IN 8/94. INCIDENT: INFANT WAS BEING LAVAGED WITH NORMAL SALINE. THE NURSE ATTEMPTED TO INSERT THE CATHETER. THE CATHETER WAS INSERTED 6 CM INTO THE ENDOTRACHEAL TUBE (3.0 SIZE OF TUBE) BUT WOULD NOT GO ANY FARTHER. THE PT BECAME BRADYCARDIC, HEART RATE DOWN TO 80, OXYGEN SATURATION DOWN TO 70, (NORMAL FOR THIS PT 95%). PT WAS IMMEDIATELY HANDBAGGED, SATURATION STILL LOW, HEARTRATE NOW 85, NORMAL 130. THE NURSE THOUGHT THE ETT MIGHT BE CRIMPED AND ASKED IF THE ETT SHOULD BE REMOVED. RPTR CAME OVER AND INSTRUCTED THE NURSE TO GET ANOTHER SUCTION TUBE. UPON USING THE NEW SUCTION CATHETER, IT PASSED THROUGH THE ETT WITHOUT ANY PROBLEM. THE NORMAL SALINE AND SECRETIONS WERE SUCTIONED OUT, THE PT'S HEART RATE AND OXYGEN SATURATION RETURNED TO NORMAL AND THE PT WAS PLACED BACK ON THE VENTILATOR. ON EXAM OF THE CATHETER, A FLAT SPOT WAS FOUND 6 CM FROM THE TIP. THIS INCIDENT WAS A LIFE-THREATENING SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CATHETER KIT, 8 FR BSY SUPERIOR HEALTHCARE GROUP, INC. 4196A

    Patients

    Seq Age Sex Outcome Treatment
    1 *