BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC CATHETER 36 FR RIGHT ANGLE SILICONE

    MDR report key: 25483 · Received August 8, 1995

    Report

    Report Number
    25483
    Event Type
    Malfunction
    Date Received
    August 8, 1995
    Date of Event
    April 7, 1995
    Report Date
    May 5, 1995
    Manufacturer
    AXIOM MEDICAL INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE PLACED IN OPERATING ROOM DURING CABG. TUBE CRACKED WHEN PT TURNED. TUBE REMOVED AND VASELINE GAUZE DRESSING APPLIED. TWO TUBE SYSTEM CONVERTED TO SINGLE TUBE ON PLEUROVAC. FACILITY DETERMINED ON 4/24/95 THAT EQUIPMENT WAS PART OF HEART PACK AND SMDA REPORT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACIC CATHETER 36 FR RIGHT ANGLE SILICONE THORACIC CATHETER KDQ AXIOM MEDICAL INC. 111136 NS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other