BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT CHEST TUBE

    MDR report key: 19129 · Received January 25, 1995

    Report

    Report Number
    MW1004850
    Event Type
    Injury
    Date Received
    January 25, 1995
    Date of Event
    December 18, 1994
    Report Date
    January 5, 1995
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER CABG, ATTEMPTED TO CONNECT PT'S PLEURAL AND MEDIASTINAL CHEST TUBES TO THE DRAINAGE UNIT. BOTH TUBES SPLIT SPIRALLY TO THE KELLY CLAMPS. CHEST TUBES HAD TO BE REMOVED. PT HAD SOME FLUID IN LUNGS BUT DID NOT REQUIRE REINSERTION OF CHEST TUBES AND DID NOT HAVE INCREASED LENGTH OF STAY. ALL LOT NUMBERS PULLED. MFR IS TESTING THIS LOT NUMBER BY STRENGTH-TESTING THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT CHEST TUBE CHEST TUBE (HEPARINIZED) KDQ AXIOM MEDICAL, INC. 9407865

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention