BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIVE SAFETY IV CATHETER

    MDR report key: 2153218 · Received June 30, 2011

    Report

    Report Number
    MW5021234
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SMITHS MEDICAL NORTH AMERICA
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV PLACEMENT, 20 GA CATHETER WITH BLOOD DRAW, SUCCESSFUL ON FIRST PLACEMENT ATTEMPT. ULTRASOUND POSITIVE DVT LEFT FOREARM AND ABOVE ELBOW 2 DAYS LATER. ANTICOAGULANT THERAPY INITIATED FOR TREATMENT OF DVT. RESOLVED WITHOUT APPARENT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIVE SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR