BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS EPIDURAL

    MDR report key: 1095 · Received July 23, 1992

    Report

    Report Number
    1095
    Event Type
    Injury
    Date Received
    July 23, 1992
    Date of Event
    July 9, 1992
    Report Date
    July 15, 1992
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    LHY
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST PLACED CATHETER; DIDN'T FUNCTION SMOOTHLY SO WITHDREW CATHETER. NOTED THAT CATHETER WAS SHEARED OFFDEVICE 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, OTHER, INVALID DATA. RESULTS OF EVALUATION: NONE OR UNKNOWN. 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 CONTINUOUS EPIDURAL EPIDURAL ANESTHESIA TRAY LHY ABBOTT LABORATORIES, INC. 47-417-DN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention