BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRAUM AXIOM ANGLE SILICONE CATHETER 36 FRENCH STOP CLOT

    MDR report key: 3689 · Received July 28, 1992

    Report

    Report Number
    3689
    Event Type
    Malfunction
    Date Received
    July 28, 1992
    Date of Event
    April 22, 1992
    Report Date
    April 30, 1992
    Manufacturer
    AXIOM MEDICAL INC.
    Product Code
    FEZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT REMOVED CHEST TUBE EASILY. DISTAL PORTION OF CHEST TUBE BROKE AT THE ANGULATION AND REMAINED IN CHEST. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE PORTION OF CHEST TUBE FROM CHEST.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUM AXIOM ANGLE SILICONE CATHETER 36 FRENCH STOP CLOT CHEST TUBE FEZ AXIOM MEDICAL INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other