BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR

    MDR report key: 24581307 · Received March 12, 2026

    Report

    Report Number
    3012307300-2026-02345
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    CAZ
    UDI-DI
    10351688076083
    PMA / PMN Number
    K092657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR (DEVICE HISTORY REVIEW) REVIEW COULD NOT BE PERFORMED DUE TO LOGISTICAL ISSUES WITH THE CLOSURE OF THE KEENE SITE AND THEIR TRANSFER OF DHR RECORDS. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS STATED THAT THE CATHETER CONNECTOR APPEARED TO BE OBSTRUCTED AND UNABLE TO INJECT MEDICATIONS THROUGH CONNECTOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639219 PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT CAZ ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6076740 10351688076083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown