BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 12934252 · Received December 6, 2021

    Report

    Report Number
    3015060232-2021-00006
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    August 24, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ACCESS VASCULAR, INC
    Product Code
    LJS
    UDI-DI
    00862559000425
    PMA / PMN Number
    K193015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). THROMBUS WAS ASSOCIATED WITH A PICC LINE. ACUTE SUPERFICIAL VENOUS THROMBOSIS (SVT) IS SEEN INVOLVING THE RIGHT BASILIC VEIN OF THE UPPER ARM. THROMBUS WAS ASSOCIATED WITH A PICC LINE." IT WAS ALSO REPORTED THAT ON (B)(6) 2021: "NO CHANGE IN PATIENT CONDITION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). ACUTE DEEP VENOUS THROMBOSIS (DVT) IS NOTED INVOLVING THE RIGHT AXILLARY VEIN(S). THROMBUS WAS ASSOCIATED WITH A PICC LINE. ACUTE SUPERFICIAL VENOUS THROMBOSIS (SVT) IS SEEN INVOLVING THE RIGHT BASILIC VEIN OF THE UPPER ARM. THROMBUS WAS ASSOCIATED WITH A PICC LINE." IT WAS ALSO REPORTED THAT ON (B)(6) 2021: "NO CHANGE IN PATIENT CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832316 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR, INC PICC-142S 03042101 00862559000425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other