BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT

    MDR report key: 17039764 · Received May 31, 2023

    Report

    Report Number
    MW5118021
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 13, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TELEFLEX MEDICAL/TELEFLEX LLC (NADC 2)
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER DISCUSSION WITH ANESTHESIOLOGIST, THE RN EXERTED HIGHER THAN NORMAL TRACTION WHEN REMOVING THE EPIDURAL CATHETER CAUSING IT TO SNAP. PER DISCUSSION WITH THE RN INVOLVED, THE CATHETER FELL OUT AS SHE WAS REMOVING THE DRESSING TAPE. ANESTHESIOLOGIST BELIEVES THE TIP OF THE EPIDURAL CATHETER REMAINS IN THE PATIENT; X-RAY CONFIRMED NO RADIOPAQUE FOREIGN BODY PRESENT. ANESTHESIOLOGIST CONTACTED MANUFACTURER OF THE KIT, WHO LET HIM KNOW THAT THEY SHOULD HAVE DONE A CT SCAN INSTEAD TO CONFIRM WHETHER OR NOT THE TIP WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898114 FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ TELEFLEX MEDICAL/TELEFLEX LLC (NADC 2) AK-05502 33F23D0021

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other