BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW FLEXTIP PLUS EPIDURAL CATHERIZATION KIT

    MDR report key: 22938523 · Received September 2, 2025

    Report

    Report Number
    MW5175465
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 26, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON REMOVAL OF THE EPIDURAL CATHETER POST VAGINAL DELIVERY, THE CATHETER BROKE. UPON VISUAL INSPECTION, THE CATHETER FRAGMENT OUTSIDE THE BODY SHOWS FRAYING AT APPROXIMATELY THE 5CM MARK. IMAGING INDICATED THERE WAS A RETAINED PORTION OF THE CATHETER. THE IMAGES SHOW BROKEN EPIDURAL CATHETER IN THE RIGHT-SIDE SPINAL CANAL OUTSIDE OF THE THECAL SAC AT L3-4 EXTENDING TO THE SUBCUTANEOUS FAT 5 CM FROM THE SKIN SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332335 ARROW FLEXTIP PLUS EPIDURAL CATHERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ TELEFLEX MEDICAL LLC 33F25E043

    Patients

    Seq Age Sex Outcome Treatment
    1 Female