BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX NRFIT EPIDURAL CONTINUOUS KIT

    MDR report key: 22081927 · Received May 24, 2025

    Report

    Report Number
    3012307300-2025-06142
    Event Type
    Injury
    Date Received
    May 24, 2025
    Date of Event
    April 14, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3: MFG ESTABLISHMENT NAME; ICU MEDICAL, INC DEVICE EVALUATION: TWO DEVICES WERE RETURNED, EPIDURAL NEEDLE AND THE CATHETER FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. IT WAS FOUND THAT THE CATHETER BROKE AND THE CROSS SECTION WAS OBLIQUE AND TORN.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EPIDURAL TUBE WAS CUT OFF ABOUT 7 CM FROM THE TIP AND BECAME A RETAINED ITEM IN THE BODY OF THE PATIENT. POSSIBLE ANATOMY LOCATIONS INCLUDE THE SUBCUTANEOUS LAYER, MUSCLE LAYER, OR THE EPIDURAL SPACE. THE INDUCTION OF ANESTHESIA WAS STOPPED, AND THE ORTHOPEDIC SURGEON WAS ASKED TO REMOVE THE TUBE. THE SUBCUTANEOUS LAYER, MUSCLE LAYER, AND EPIDURAL SPACE WERE EXAMINED BUT COULD NOT BE FOUND. SINCE THERE WAS NO HOLE RECOGNIZED ON THE DURA MATER, IT WAS CONCLUDED THAT IT WAS LIKELY RETAINED IN THE MUSCLE LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714498 PORTEX NRFIT EPIDURAL CONTINUOUS KIT ANESTHESIA CONDUCTION KIT CAZ ICU MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male