BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLICK SET UNCUFFED ENDOTRACHEAL TUBE WITH SURELOC

    MDR report key: 17567 · Received November 11, 1994

    Report

    Report Number
    MW1003989
    Event Type
    Malfunction
    Date Received
    November 11, 1994
    Date of Event
    October 28, 1994
    Report Date
    November 2, 1994
    Manufacturer
    POLAMEDCO, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CO DISTRIBUTED APPROX 74,000 UNITS (INCLUDING ALL SIZES) OF THE PRODUCT 1500U DURING 1994; 67,000 UNITS OF THE PRODUCT 1500U DURING 1993; 66,000 UNITS OF THE PRODUCT 1500U DURING 1192. OTHER EVENTS IDENTICICAL TO THE SUBJECT EVENT FOR CO P/N 1500U HAS NOT BEEN REPORTED TO CO DURING 1992, 1993, OR 1994. THREE SIMILAR, BUT NOT IDENTICAL, EVENTS OF CONNECTOR DISCONNECTED HAVE BEEN REPORTED IN THE YRS 1992, 1993, AND 1994, IN THE SIMILAR EVENTS, DISCONNECT WAS NOT REPORTED TO HAVE RESULTED FROM THE WITHDRAWL OF THE STYLET FROM THE ENDOTRACHEAL TUBE, BUT RATHER FROM THE EXERTION OF EXCESSIVE PULL FORCE ON THE CONNECTOR FROM A BREATHING CIRCUIT OR OTHER DEVICE. IN NONE OF THESE 3 EVENT WAS DEATH OR SERIOUS INJURY REPORTED. AS AN ADDED SAFEGUARD AGAINST ACCIDENTAL DISCONNECT OF THE CONNECTOR FROM THE TUBE, CO ADDED A FLANGE OR EXTERNAL RING OF PVC BETWEEN THE CONNECTOR AND THE DISTAL END OF THE TUBE, TO MAKE ACCIDENTAL REMOVAL OF THE CONNECTOR UNLIKELY UNDER NORMAL OPERATING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLICK SET UNCUFFED ENDOTRACHEAL TUBE WITH SURELOC BTR POLAMEDCO, INC. 2492

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY