BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH

    MDR report key: 6031 · Received May 18, 1993

    Report

    Report Number
    2183502-1993-00007
    Event Type
    Injury
    Date Received
    May 18, 1993
    Date of Event
    April 17, 1993
    Report Date
    April 19, 1993
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON INCIDENT DATE IT WAS DETERMINED THAT THE CATHETER WAS LEAKING FROM A SMALL HOLE (OUTSIDE OF BODY). INITIAL ATTEMPT TO REMOVE THE CATHETER WAS UNSUCCESSFUL. X-RAY REVEALED THAT CATHETER WAS LODGED IN AN AREA BETWEEN THE AXILLA AND ELBOW. THE PATIENT WAS REFERRED TO A SURGEON WHO PERFORMED A CUT DOWN IN THE ANTECUBITAL SPACE AND SUCCESSFULLY RETREIVED THE CATHETER. IT WAS NOTED THAT THE REMOVED CATHETER TIP HAD AN APOPROX. FIVE INCH FIBRIN CLOT ADHERED TO IT. THE REORTER STATED THAT TH EPATIENT MAY HAVE BEEN NON-COMPLIANT IN CARING FOR CATHETERDEVICE 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH Implant PERIPHERALLY INSERTED CENTRAL CATHETER DXG LUTHER MEDICAL PRODUCTS, INC. LMP1071

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention