BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID OR HYDROPICC - COMPLAINANT DID NOT SPECIFY WHICH DEVICE

    MDR report key: 19784107 · Received July 19, 2024

    Report

    Report Number
    3015060232-2024-00016
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED A BREAK IN A CATHETER LINE ON (B)(6) 2024 AND PROVIDED AN IMAGE OF THE LINE. THE IMAGE APPEARS TO SHOW A BREAK IN THE LINE AT THE 7CM MARK. THE CATHETER WAS OBSERVED TO BE LEAKING MEDICATION UNDER THE SKIN AND CAUSING IRRITATION. THE CATHETER WAS DISPOSED OF BY THE USER AND REPLACED WITH ANOTHER CATHETER. POWER INJECTION WAS NOT BEING USED AND THERE WERE NO SIGNS OF OCCLUSIONS OR KINKS IN LINE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE COMPLAINANT. FROM THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO IDENTIFY WHETHER THE CATHETER IS A MIDLINE OR A PICC. DUE TO THE LIMITED INFORMATION AVAILABLE, THE CAUSE OF THE BREAK CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    REPORT OF A BREAK IN A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918913 HYDROMID OR HYDROPICC - COMPLAINANT DID NOT SPECIFY WHICH DEVICE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR. INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other