BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROMID

    MDR report key: 12023156 · Received June 18, 2021

    Report

    Report Number
    3015060232-2021-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 23, 2021
    Report Date
    June 9, 2021
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    FOZ
    UDI-DI
    00862559000449
    PMA / PMN Number
    K203069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CLINICIAN THE CATHETER HAD BEEN PLACED IN THE PATIENT'S LEFT BRACHIAL VEIN ON (B)(6) 2021 WITHOUT ISSUE ("SEAMLESS INSERTION PER MY TEAM NOTHING OUT OF ORDINARY"). ACCORDING TO THE CLINICIAN'S NOTES, THE CATHETER WAS TRIMMED TO 16CM, WHERE 15 CM WAS INSERTED INTO THE PATIENT'S VEIN AND 1 CM REMAINED OUTSIDE THE INSERTION POINT. THE CLINICIAN ATTRIBUTED THE CAUSE OF THE OCCLUDED CATHETER TO THE HOSPITAL'S ". VERY POOR CARE AND MAINTENANCE" OF THE DEVICE. A REVIEW OF THE AFFECTED LOT'S DHR DID NOT REVEAL ANY DEVIATIONS, ANOMALIES, OR OTHER ISSUES WHICH WOULD CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT THE HYDROMID CATHETER HAD OCCLUDED 2 DAYS AFTER BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925945 HYDROMID MIDLINE CATHETER FOZ ACCESS VASCULAR, INC. MID-141 04012102 00862559000449

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other