BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PEEL AWAY SYSTEM

    MDR report key: 432080 · Received December 5, 2002

    Report

    Report Number
    MW1026927
    Event Type
    Injury
    Date Received
    December 5, 2002
    Date of Event
    November 4, 2002
    Report Date
    December 5, 2002
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PICC LINE INSERTED. ACCORDING TO THE DOCUMENTATION, 15 CMS WERE INSERTED. ON EVENT DATE, THE SITE WAS FOUND WET AND LEAKING. THE DRESSING WAS REMOVED AND APPROXIMATELY 2 CMS OF THE PICC CATHETER WAS FOUND OUTSIDE THE PATIENT WITH REMAINING 13 CMS OF THE PICC CATHETER WAS FOUND OUTSIDE THE PATIENT WITH THE REMAINING 13 CMS UNACCOUNTED FOR. STAT LEFT ARM AND CHEST XRAY COMPLETED - NEGATIVE FOR FOREIGN BODY. CHEST FLUOROSCOPY COMPLETE AND NEGATIVE FOR FOREIGN BODY. ABDOMINAL X-RAY AND TOTAL BODY SURVEY COMPLETED AND NEGATIVE FOR FOREIGN BODY. CARDIAC ECHOGRAM COMPLETED AND NOTED AN ECHOGENIC LINEAR STRUCTURE IN THE RIGHT ATRIUM OF THE HEART. INTERVENTIONAL RADIOLOGY CONDUCTED TO REMOVE FOREIGN BODY UNDER FLUOROSCOPY WITHOUT SUCCESS. NO PICC LINE IDENTIFIED AT TIME OF PROCEDURE. REPEAT ECHOGRAM COMPLETED. NO FOREIGN BODY IDENTIFIED. PT ASYMPTOMATIC. STOOL MONITORED FOR NEGATIVE RESULTS. DISCHARGED 11/21002 TO FOLLOW-UP WITH SURGEON AND PRIVATE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PEEL AWAY SYSTEM PERIPHERALLY INSERTED CENTRAL CATHETER DQO LUTHER MEDICAL PRODUCTS, INC. D14453 2221401

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R PATIENT RECEIVING ANTIBIOTICS EVERY 8 HOURS| THROUGH PICC LINE.