BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT CHEST TUBE

    MDR report key: 19132 · Received January 25, 1995

    Report

    Report Number
    MW1004851
    Event Type
    Injury
    Date Received
    January 25, 1995
    Date of Event
    January 5, 1995
    Report Date
    January 11, 1995
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CABG PROCEDURE, A 36 STRAIGHT FRENCH CHEST TUBE WAS PLACED IN THE MEDIASTINUM. STERNAL WIRES WERE INSERTED, AND THE DRAINAGE WAS CONNECTED TO THE CHEST TUBE. THE TUBE SPLIT SPIRALLY TOWARD THE INCISION. THE TUBE WAS SHORTENED AND REATTACHED TO THE DRAINAGE UNIT. IT CONTINUED TO SPLIT IN TWO. THE STERNAL WIRE AND CHEST TUBE WERE REMOVED AND A NEW CHEST TUBE PLACED WITHOUT DIFFICULTY IN THE MEDIASTINUM WAS CONNECTED TO THE DRAINAGE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT CHEST TUBE HEPARINIZED CHEST TUBE KDQ AXIOM MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention