BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 23360409 · Received October 22, 2025

    Report

    Report Number
    1217052-2025-00105
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    August 31, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    CAZ
    UDI-DI
    15019517095166
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED DUE TO LOGISTICAL ISSUES WITH THE CLOSURE OF THE KEENE SITE AND THEIR TRANSFER OF DHR RECORDS. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, WHICH CONFIRMED THE ISSUE OF THE CATHETER BEING SEVERED. THE PROBABLE CAUSE WAS UNKNOWN. THE TIMEFRAME OF THE OCCURRENCE COULD NOT BE DETERMINED. NO FURTHER ACTION WAS TAKEN.

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS STATED THAT THE CRNA WAS PLACING EPIDURAL FOR LABOR DELIVERY. WHEN HE ATTEMPTED TO PULL BACK ON THE CATHETER, THE CATHETER BROKE. APPROXIMATELY 5 CM OF THE CATHETER WAS LEFT IN THE PATIENT'S BACK. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243146 PORTEX ANESTHESIA CONDUCTION KIT CAZ ICU MEDICAL, INC. 6131011 15019517095166

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female