BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHO-CATH

    MDR report key: 6719 · Received October 4, 1993

    Report

    Report Number
    6719
    Event Type
    Malfunction
    Date Received
    October 4, 1993
    Date of Event
    December 19, 1991
    Report Date
    February 19, 1992
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    KTR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LEFT THORACOTOMY AND LEFT PNEUMONECTOMY. AT END OF CASE ANESTHESIA WAS UNABLE TO EXTUBATE PATIENT. FIBEROPTIC BRONCHOSCOPY PERFORMED AND INCISION RE-0PENED. ENDOBRONCHIAL TUBE INADVERTENTLY SUTURED. SUTURE CUT AND ENDOBRONCHIAL TUBE REMOVED. PATIENT DISCHARGED 12/28/91 WITHOUT COMPLICATIONS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: NONE OR UNKNOWN, OTHER, INVALID DATA. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHO-CATH ENDOBRONCHIAL TUBE KTR MALLINCKRODT CRITICAL CARE R8602 ML01680

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other