BEUDAMED
    FDA Adverse Event Summary report: N

    AXIOM THORACIC CATH

    MDR report key: 92650 · Received February 9, 1995

    Report

    Report Number
    92650
    Date Received
    February 9, 1995
    Date of Event
    August 8, 1994
    Report Date
    August 12, 1994
    Manufacturer
    AXIOM MEDICAL ,INC.
    Product Code
    KDQ
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE BROKE UPON REMOVAL BY PHYSICIAN LEAVING APPROX. SIX INCHES IN THE PT; REMOVED UNDER FLUOROSCOPE WITH HEMASTAT. ANOTHER CHEST TUBE WAS PLACED AFTER REMOVAL OF FRAGMENT WITHOUT INCIDENT AND WITH MINIMAL RISK TO THE PT. 8/17/94 RECEIVED COPY OF LETTER FROM CO TO FDA WITH TEST RESULTS OF TUBE THAT WAS SENT TO CO FOR EVAL. EVIDENCE OF BREAKAGE ACROSS FROM MOST PROXIMAL DRAINAGE HOLE "PROBABLY DUE TO NICK OR PUNCTURE OF THE TUBE". INFO SHARED WITH SAFETY COMMITTEE AND VP OF MEDICAL AFFAIRS TO SHARE WITH INSERTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM THORACIC CATH 36 FRENCH STRAIGHT THORACIC CATHETER KDQ AXIOM MEDICAL ,INC. * 9307808

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR