BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX EPIDURAL KIT

    MDR report key: 8306073 · Received February 4, 2019

    Report

    Report Number
    MW5083691
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    October 17, 2018
    Report Date
    January 31, 2019
    Manufacturer
    ARROW/ TELEFLEX INC
    Product Code
    CAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ARROW EPIDURAL KIT WAS USED ON A CSE. PLACEMENT WENT EASILY ALTHOUGH THERE ARE MINIMAL DEPTH MARKINGS ON THIS CATHETER. REMOVED CATHETER AT THE END OF THE PROCEDURE WITH SLIGHT INITIAL RESISTANCE BUT END THAT WAS REMOVED LOOKED LIKE THE METAL TIP OF THE ORIGINAL CATHETER. I WAS CONTACTED BY PHYSICIAN APPROX 2 MONTHS LATER WHEN THE PATIENT WAS HAVING A FLURO-GUIDED ESI AND A FOREIGN BODY WAS SEEN BETWEEN L2-3 SPACE ON FLUORO AND PRESUMED TO BE RETAINED EPIDURAL CATHETER. PATIENT ASYMPTOMATIC- AND RECOMMENDED FOLLOW-UP W/ NEUROSURGEON TO SEE IF THE FOREIGN BODY NEEDS REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96547 TELEFLEX EPIDURAL KIT ANESTHESIA CONDUCTION KIT CAZ ARROW/ TELEFLEX INC AK-05000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other