BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ET TUBE, 7.0

    MDR report key: 12104 · Received March 17, 1994

    Report

    Report Number
    MW1001138
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    February 25, 1994
    Report Date
    March 3, 1994
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ET TUBE CHECKED PRIOR TO PLACEMENT, CUFF NOTED TO INFLATE AND AIR WAS REMOVED. WHILE PT WAS INTUBATED, ET BECAME LOOSE. CHECK BULB WAS NOT TIGHT WITH AIR. FOUR CC AIR WAS ADDED. LATER, BULB AGAIN NOT FULL OF AIR. COMPLIANCE BECOMING WORSE AND TUBE WAS REPLACED. AFTER RETURN TO AMBULANCE, BASE CREW AGAIN CHECKED TUBE AND IT WOULD NOT HOLD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ET TUBE, 7.0 ET TUBE STERILE SINGLE 10 MM SHERIDAN CATHETER CORP. 018189

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other