BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMEDIATE HI-LO TRACHEAL TUBE, CUFFED - MURPHY EYE

    MDR report key: 5101 · Received April 27, 1993

    Report

    Report Number
    5101
    Event Type
    Injury
    Date Received
    April 27, 1993
    Date of Event
    February 25, 1993
    Report Date
    March 25, 1993
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BSK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH ENDOTRACHEAL TUBE BEING MECHANICALLY VENTILATED. DEVELOPED AIR LEAK WITH RESULT INADEQUATE VENTILATION. REQUIRED REINTUBATION TO MAINTAIN VENTILATION: CUFF ON TUBE FOUND TO HAVE BLOWNDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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: MATERIAL DEGRADATION/DETERIORATION, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDIATE HI-LO TRACHEAL TUBE, CUFFED - MURPHY EYE ENDOTRACHEAL TUBE BSK MALLINCKRODT CRITICAL CARE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention