BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROMID

    MDR report key: 12069895 · Received June 25, 2021

    Report

    Report Number
    3015060232-2021-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 21, 2021
    Report Date
    June 25, 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 OCCLUSION WAS A RESULT OF EITHER "NO FLUSHING OR POOR FLUSHING" OF THE DEVICE BY THE HOSPITAL'S STAFF; PROPER CARE AND MAINTENANCE OF THE HYDROMID DEVICE IS PRESCRIBED IN ITS IFU. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968801 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR, INC. MID-141 06072101 00862559000449

    Patients

    Seq Age Sex Outcome Treatment
    1