BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTIVE PLUS SAFETY IV CATHETER

    MDR report key: 7586330 · Received June 8, 2018

    Report

    Report Number
    MW5077711
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 18, 2018
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2018 FOR REPORT MW5077711.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PRESENTED TO ED WITH IV PLACE. ON (B)(6) 2018 AT APPROXIMATELY 1530 EEG TECH WAS PREPARING PATIENT FOR EEG NOTICED SOME BLOOD AT THE IV SITE AND CALLED THE RN TO ASSESS THE IV SITE. RN DISCONTINUED IV DUE TO INFILTRATION AND UPON INSPECTION OF THE CATHETER NOTICED THE TIP WAS MISSING. US CONFIRMED THE IV CATHETER TIP TO BE LODGED IN THE BASILIC VEIN OF THE LEFT FOREARM. VASCULAR SURGERY WAS CONSULTED AND SURGERY FOR REMOVAL OF THE CATHETER TIP IS SCHEDULED FOR (B)(6) 2018. THE PORTION OF THE PRODUCT THAT WAS REMOVED FROM THE PATIENT HAS BEEN SEQUESTERED BY MATERIALS MANAGEMENT. MANUFACTURER HAS BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426630 PROTECTIVE PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT FOZ SMITHS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention