BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEST TUBE

    MDR report key: 3072 · Received July 10, 1992

    Report

    Report Number
    3072
    Event Type
    Injury
    Date Received
    July 10, 1992
    Date of Event
    April 16, 1992
    Report Date
    April 23, 1992
    Manufacturer
    ARGYLE
    Product Code
    BTS
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TWO #36 FRENCH ARGYLE CHEST TUBES PLACED DURING SURGERY ON APRIL 14, 1992. ON APRIL 16, 1992 THE PHYSICIAN DISCONTINUED THE CHEST TUBE. ONE CHEST TUBE WAS DISCONTINUED WITHOUT DIFFICULTY. THE OTHER CHEST TUBE SNAPPED AND BROKE AT THE SKIN LINE. THE PATIENT HAD TOHAVE THIS PORTION (APPROXIMATELY 8 INCHES) SURGICALLY REMOVED. ON EXAMINATION, A SUTURE THREAD WAS NOTED TO BE AROUND THE DISTAL PORTION OF THE CHEST TUBE NEAR THE PLACE WHERE THE BREAK OCCURREDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEST TUBE BTS ARGYLE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention