BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW FLEXTIP PLUS CATHETERIZATION KIT

    MDR report key: 10128238 · Received June 5, 2020

    Report

    Report Number
    MW5094868
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    February 2, 2020
    Report Date
    May 20, 2020
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING RIGHT TOTAL HIP ARTHROPLASTY. AT END OF PROCEDURE, STAFF REMOVED SPINAL EPIDURAL CATHETER AND NOTICED THAT BLACK TIP WAS NOT VISIBLE. PATIENT UNDERWENT CT SCAN, CATHETER TIP NOTED AT L4- L5. PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2020 FOR REMOVAL OF CATHETER TIP. STAFF REPORTED NO UNUSUAL RESISTANCE WHEN PULLING CATHETER DURING INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587738 ARROW FLEXTIP PLUS CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ HS-05501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other