BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTIP PLUS EPIDURAL CATHETER

    MDR report key: 8531448 · Received April 18, 2019

    Report

    Report Number
    MW5085988
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 16, 2019
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    CAZ
    UDI-DI
    60801902005139
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EPIDURAL CATHETER FRACTURED WHEN BEING REMOVED AND REQUIRED SURGICAL INTERVENTION TO REMOVE RETAINED CATHETER PORTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318861 FLEXTIP PLUS EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) 19 GAUGE CATHETER 23F19C0021 60801902005139

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention