BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER IV AUTOGUARD 20 GA

    MDR report key: 7200195 · Received January 16, 2018

    Report

    Report Number
    MW5074625
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 12, 2018
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO START A #20 GAUGE IV IN ED. HE INSPECTED IT PRIOR TO INSERTION AND THE CATHETER LOOKED LIKE IT ROUTINELY DOES, HE INDICATED THAT HE DID NOT STARE AT THE CATHETER FOR A LONG PERIOD OF TIME BUT RATHER A FEW SECONDS BEFORE INSERTING, THE SITE WAS PREPPED AS HE NORMALLY DOES AND UPON INSERTION, THE PT TENSED UP. HE FLUSHED IT AND IT INFILTRATED. NURSE INDICATED THAT HE PULLED THE CATH OUT AND HEARD IT "SNAP OFF". HE IMMEDIATELY WENT TO NOTIFY THE PHYSICIAN, IN WHICH ORDERS WERE RECEIVED TO OCL THE ARM FOR MOBILIZATION AND PHYSICIAN MADE CALLS TO GENERAL SURGEON. OUR SURGEON INDICATED THAT THE PT NEEDED A VASCULAR SURGEON THEREFORE, THE PT WAS TRANSFERRED TO A LARGER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41022 CATHETER IV AUTOGUARD 20 GA CATHETER FOZ SMITHS MEDICAL ASD 3066 3521495

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization