BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX CLEAR CUFF PRESSURE INFUSOR

    MDR report key: 23126845 · Received September 23, 2025

    Report

    Report Number
    1526863-2025-00112
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 21, 2025
    Report Date
    November 4, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KDZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR REPORTED LOT# ABOUT THE REPORTED PROBLEM DURING LOT HISTORY REVIEW. THE SAMPLE WAS DISCARDED BY THE HOSPITAL AS NOTED IN THE COMPLAINT PRODUCT RETURN SECTION. 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.

    Additional Manufacturer Narrative · 0

    H3: DEVICE NOT RECEIVED BY MANUFACTURER.¿ A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS STATED IN THE REPORT THAT WHILE MONITORING A PATIENT'S INVASIVE BLOOD PRESSURE, A NURSE DISCOVERED A LEAK IN THE PRESSURE BAG, LEADING TO BACKFLOW OF BLOOD THROUGH THE PATIENT'S ARTERIAL CATHETER. THE NURSE IMMEDIATELY REPLACED THE PRESSURE BAG AND CONTINUED INVASIVE BLOOD PRESSURE MONITORING. THERE WAS PATIENT INVOLVEMENT, WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201404 MEDEX CLEAR CUFF PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KDZ SMITHS MEDICAL ASD, INC. 4425268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown