BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENT CATHETER

    MDR report key: 43223 · Received October 18, 1996

    Report

    Report Number
    1713910-1996-00024
    Event Type
    Malfunction
    Date Received
    October 18, 1996
    Date of Event
    August 26, 1996
    Report Date
    October 18, 1996
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF THE CATHETER, THE M.D EXPERIENCED DIFFICULTY IN PLACING THE CATHETER. HE HELD THE CATHETER IN PLACE AND REMOVED THE STYLET. THEN THE STYLET WAS RE-INSERTED AND SOME RESISTANCE WAS FELT. THE CATHETER WAS REMOVED AND IT WAS DISCOVERED THE STYLET TIP HAD EXITED THE CATHETER SIDE HOLES DURING RE-INSERTION OF THE STYLET. THE UNIT WAS REPLACED WITH NO ADVERSE IMPACT TO THE PT. THE INSTRUCTIONS FOR USE PROVIDED IN EACH CARTON OF CATHETERS CAUTIONS UNDER ITEM #6: WARNING: TO AVOID PERFORATION OF THE HEART WALL, USE STYLET ONLY TO FACILITATE INITIAL PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENT CATHETER VENTRICULAR VENT CATHETER DWF RESEARCH MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention