BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH

    MDR report key: 14190 · Received June 21, 1994

    Report

    Report Number
    MW1002522
    Event Type
    Malfunction
    Date Received
    June 21, 1994
    Date of Event
    June 2, 1994
    Report Date
    June 7, 1994
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CENTRAL LINE CATHETER WAS THREADED WITHOUT DIFFICULTY. PLACEMENT VERIFIED IN SUPERIOR VENA CAVA, BY X-RAY. RPTR WAS UNABLE TO REMOVE STYLET; IT SEEMED TO BE STUCK. SALINE AND PRESSURE WERE APPLIED APPROX ONE AND A HALF INCHES ABOVE THE INSERTION SITE WHILE ATTEMPTING TO WITHDRAW STYLET. IN THE INTERIM, THE WHITE CAP ATTACHED TO THE GUIDE WIRE FELL OFF. DURING THESE EVENTS THERE WAS A PHONE CONSULTATION WITH THE CLINICAL REP. RPTR WAS UNABLE TO REMOVE STYLET AND CATHETER HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PERIPHERAL CENTRAL CATHETER DQO HDC CORP. 1019

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other