BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8411494 · Received March 12, 2019

    Report

    Report Number
    8411494
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 27, 2019
    Manufacturer
    INTERRAD MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER THE VASCULAR RN PLACED A MIDLINE CATHETER IN THE UPPER ARM, THE SUBCUTANEOUS ANCHOR WAS PLACED BUT WOULD NOT LOCK DOWN. A NEW SECURACATH WAS OBTAINED AND PLACED WITHOUT DIFFICULTY. THE PATIENT WAS NOT HARMED, THE PROCEDURE TOOK A BIT LONGER. MANUFACTURER RESPONSE FOR IV ANCHOR DEVICE, 5 FRENCH SECURACATH (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO MANUFACTURER. RMA# (B)(4). EQUIPMENT MAILED VIA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204586 SECURACATH CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS INTERRAD MEDICAL, INC 5F A1827

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA