BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L CATH CATHETER SYSTEM

    MDR report key: 226081 · Received June 1, 1999

    Report

    Report Number
    2022441-1999-00006
    Event Type
    Malfunction
    Date Received
    June 1, 1999
    Date of Event
    April 17, 1999
    Report Date
    May 28, 1999
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN L-CATH PICC WAS BEING PULLED OUT IN THE HOMECARE SETTING AND IT BROKE OFF. THE PATIENT WAS ADMITTED WITH 9 CMS IN HIS LEFT ARM. THE PATIENT RELAYED THE STORY THAT THE NURSE MET RESISTANCE IN REMOVING THE CATHETER AND THAT SHE PUT TENSION ON THE CATHETER AND TAPED IT. SHE THEN PROCEEDED TO REMOVE IT WITHOUT ANY PROBLEMS. HOWEVER, PART OF THE CATHETER REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L CATH CATHETER SYSTEM INTRAVASCULAR CATHETER DQO LUTHER MEDICAL PRODUCTS, INC. NA LMP 5335

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention