BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POWER MIDLINE

    MDR report key: 24879101 · Received April 14, 2026

    Report

    Report Number
    3006260740-2026-02476
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 13, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    PND
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED IN LITERATURE REVIEW THAT AN OFF LABEL USE ISSUE INVOLVING BD PRODUCTS. IT WAS REPORTED THAT ULTRAFILTRATION (UF) IS A DIALYSIS MODALITY CONSISTING OF THE REMOVAL OF WATER AND SOLUTES THROUGH A SEMIPERMEABLE MEMBRANE. IT CAN BE USED IN PATIENTS WITH DECOMPENSATED HEART FAILURE (HF) WITH VOLUME OVERLOAD DESPITE MAXIMUM DIURETIC THERAPY. ITS USE ON HOSPITAL WARDS, USING PERIPHERAL VENOUS ACCESS, FACILITATES ITS AVAILABILITY. WE ANALYZED THE EXPERIENCE WITH UF VIA PERIPHERAL VENOUS ACCESS PERFORMED ON HOSPITAL WARDS IN PATIENTS WITH ADVANCED HF REFRACTORY TO DIURETICS. THIS WAS A RETROSPECTIVE STUDY. FROM MARCH 2019 TO DECEMBER 2021, THE PROCEDURE WAS PERFORMED IN 16 PATIENTS ADMITTED WITH CONGESTION RESISTANT TO DIURETICS (CONGESTIVE SIGNS AND SYMPTOMS DESPITE TREATMENT WITH HIGH-DOSE INTRAVENOUS FUROSEMIDE WITH SEQUENTIAL NEPHRON BLOCKADE). UF WAS PERFORMED USING A 5FR VENOUS LINE WITH 18G DUAL LUMEN (POWER MIDLINE, BARD ACCESS SYSTEMS, USA) SHORTENED TO 10 CM AND PLACED IN THE BASILIC VEIN. THE DEVICE USED WAS AQUADEX SMARTFLOW SYSTEM (NUWELLIS INC, USA). THE STARTING PARAMETERS WERE: BLOOD FLOW, 40 ML MIN; UF RATE, 150 ML H. DURING UF (PROGRAMMED FOR 24 H), ALL DIURETICS WERE STOPPED. NO FURTHER DETAILS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933386 BARD POWER MIDLINE MIDLINE CATHETER PND C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other