BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 10140052 · Received June 10, 2020

    Report

    Report Number
    3015060232-2020-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00862559000418
    PMA / PMN Number
    K193015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, A FOLLOW UP PHONE CONVERSATION WITH THE CLINICIAN REVEALED THAT, THE DEVICE WAS NOT SUTURED, BUT SECURED BY A GRIP-LOK DEVICE. IT WAS ALSO NOTED THAT A FRACTURE WAS OBSERVED IN PROXIMITY TO THE SUTURE WING-TO-CATHETER JOINT. THE DEVICE WAS EXPLANTED FROM THE PATIENT, AND SUBSEQUENTLY REPLACED WITH ANOTHER HYDROPICC WITHOUT INCIDENT ON THE SAME DATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD COMPLETED ALL THERAPY ON (B)(6) 2020, AND THE HYDROPICC WAS REMOVED WITHOUT INCIDENT. THE CLINICIAN STATED THAT THERE WERE NO COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYDROPICC WAS PLACED ON (B)(6) 2020 WITHOUT ISSUE. THEN, ON (B)(6) 2020, THE CLINICIAN WAS CONTACTED TO CONSULT ON AN ALLEGED LEAKING CATHETER. ON (B)(6) 2020, THE CLINICIAN COMMUNICATED, BY EMAIL, THAT "...MY UPSTANDING[SIC] IS PT ACCIDENTALLY PULLED ON THE LINE IT WAS FOUND OUT A FEW 3CM SECURED ONLY BY TEGADERM BY THE BEDSIDE NURSE AND WE WERE CONSULTED FOR LEAKING LINE. MY NURSE FOUND THE PROXIMAL END DRIED, KINDER[SIC] AND CRACKED.""UPON STERILE SALINE INSTALLATION.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604187 HYDROPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ACCESS VASCULAR, INC. PICC-142 03022003 00862559000418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other