BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETER

    MDR report key: 3909 · Received June 30, 1992

    Report

    Report Number
    3909
    Event Type
    Malfunction
    Date Received
    June 30, 1992
    Date of Event
    March 5, 1992
    Report Date
    June 30, 1992
    Manufacturer
    ABBOTT LABORTORIES
    Product Code
    LHG
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 3/5/92, CRNA ATTEMPTING EPIDURAL ANESTHESIA FOR LABOR AND DELIVERAL PATIENT. THE CATHTER WOULD NOT THREAD INTO THE EPIDURAL SPAE. CRNA SAID HE FELT LIKE HE HIT BONE SO HE BEGAN WITHDRAWING THE CATHETER AND FELT IT SNAP. CRNA THEN PULLED THE INTRODUCTER WITH THE CATHETER OUT AND FOUND IT TO BE FRAYED AT THE DISTAL END. X-RAYS REVEALED A TIP SHEARED DISTAL PORTION OF THE EPIDURAL CATHETER IN THE LUMBR AREA. NO PREENT ACTIONS ARE PLANNED FOR THE PATIENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER CONTINUOUS EPIDURAL LHG ABBOTT LABORTORIES 477505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other