BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

    MDR report key: 7970410 · Received October 16, 2018

    Report

    Report Number
    3009549229-2018-00002
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ACCESS SCIENTIFIC, LLC
    Product Code
    DYB
    UDI-DI
    10859821006527
    PMA / PMN Number
    K131300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE FLOOR NURSE ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT'S ARM. DURING THE CATHETER REMOVAL PROCESS, THE NURSE REPORTED THAT IT WAS DIFFICULT AND THAT THE PATIENT APPEARED TO BE IN PAIN. UPON REMOVAL OF THE CATHETER FROM THE PATIENT'S ARM, THE NURSE OBSERVED AN UNKNOWN ANGLE TO THE CATHETER TIP. THE INCIDENT WAS DISCUSSED AMONG THE HOSPITAL BOARD AND THEY SUSPECT THE INCIDENT WAS DUE TO USER ERROR. FURTHERMORE, AN XRAY WAS TAKEN ON THE PATIENT'S ARM AND IT APPEARED THAT REMNANTS OF THE CATHETER REMAINED IN THE PATIENT'S ARM. THE HOSPITAL CONTINUED TO MONITOR THE PATIENT'S CURRENT CONDITION AND INTERVENTION WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812291 POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER INTRODUCER CATHETER DYB ACCESS SCIENTIFIC, LLC 3FR ED 10859821006527

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization