BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 10514468 · Received September 10, 2020

    Report

    Report Number
    3015060232-2020-00004
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 24, 2020
    Report Date
    November 17, 2020
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00862559000418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP TELEPHONE CONVERSATION WITH MR. BUNCH REALIZED THAT THE CATHETER HAD NOT KINKED OR CRACKED (AS ORIGINALLY REPORTED), AND THAT THE DEFECT WAS CLEARLY A HOLE IN THE CATHETER. THE HYDROPIC WAS EXPLANTED AND REPLACED WITH A MIDLINE CATHETER SINCE A PICC WAS NO LONGER NEEDED FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HYDROPIC CATHETER HAD BEEN SUCCESSFULLY IMPLANTED ON (B)(6) 2020 WITHOUT ANY ISSUES. THEN, NINE DAYS LATER, IT WAS REPORTED THAT THE CATHETER HAD RETRACTED APPROXIMATELY 6 CM OUTSIDE THE PATIENT AND THAT A CRACK IN THE CATHETER BECAME EVIDENT AFTER ATTEMPTING TO FLUSH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980320 HYDROPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ACCESS VASCULAR, INC. PICC-142 07312002 00862559000418

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other