BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 19279284 · Received May 9, 2024

    Report

    Report Number
    3015060232-2024-00009
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 11, 2024
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    FOZ
    UDI-DI
    00850030354358
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED THAT THE MIDLINE WAS INSERTED ON (B)(6) 2024 AND WAS REMOVED ON 11 APRIL 2024 DUE TO OBSERVED INFILTRATION. THE LINE WAS NOT REPLACED. NO PATIENT HARM WAS REPORTED. THE LINE WAS RETURNED TO AVI FOR INVESTIGATION. A KINK WAS OBSERVED AT 4CM FROM THE SUTURE WING TIP. A LEAK POINT WAS IDENTIFIED 90 DEGREES FROM THE KINK. THE LOT HISTORY RECORDS WERE REVIEWED AND NO NONCONFORMANCES WERE IDENTIFIED. THE ROOT CAUSE OF THE KINK AND BREAK IN THE LINE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A BREAK IN A MIDLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490408 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR INC. MID-141 CM 01162411 00850030354358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other