BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE PRO

    MDR report key: 25086823 · Received May 5, 2026

    Report

    Report Number
    3006260740-2026-03154
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 18, 2026
    Report Date
    April 24, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    UDI-DI
    00801741140631
    PMA / PMN Number
    K162377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE IS A DEFECT IN THE CATHETER ITSELF AT THE HUB-CATHETER CONNECTION. IT IS A VERY SLIGHT HOLD, AND IT LEAKS. LINE LEAKAGE WAS DISCOVERED ON 04/18/26, LINE WAS PLACED ON (B)(6) 2026 (20/10 PG) TO RT BASILIC VEIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206506 POWERGLIDE PRO MIDLINE CATHETER FOZ C.R. BARD, INC. (BASD) -3006260740 N/A RELN2967 00801741140631

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Other