BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV SAFETY IV CATHETER

    MDR report key: 2140479 · Received June 23, 2011

    Report

    Report Number
    2140479
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 16, 2011
    Report Date
    June 15, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE INSERTED A 20G PROTECTIV IV CATHETER INTO THE PATIENT AND NOTED THE FLASH OF BLOOD RETURN. THE NURSE PROCEEDED TO ADVANCE THE CATHETER AND MET SOME RESISTANCE. UPON INSPECTION, IT WAS NOTED THAT THE NEEDLE HAD ADVANCED COMPLETELY THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV SAFETY IV CATHETER IV CATHETER FOZ SMITHS MEDICAL 3067 1933747

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR