BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTIP PLUS EPIDURAL CATHETER

    MDR report key: 14855359 · Received June 28, 2022

    Report

    Report Number
    MW5110581
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ARROW INTERNATIONAL, LLC
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EPIDURAL CATHETER LODGED AND UNABLE TO REMOVE. CATHETER BROKE OFF IN PATIENT WHEN REMOVED UNDER FLUOROSCOPY. THE INCIDENT WAS REPORTED TO THE MANUFACTURER. CATHETER WILL BE RETURNED TO THE MANUFACTURER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846171 FLEXTIP PLUS EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL, LLC 13F22D0513

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female