BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 10684564 · Received October 15, 2020

    Report

    Report Number
    3015060232-2020-00005
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00862559000418
    PMA / PMN Number
    K193015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SUSPECT DEVICE, IT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HYDROPICC REPLACED AN UNKNOWN PICC DEVICE (NOT A HYDROPICC), WHICH MIGRATED INTO THE PATIENT'S AXILLARY VEIN, OCCLUDING THAT VEIN AND CAUSING A CLOT AND PHLEBITIS IN HIS RIGHT ARM; THE PICC HAD BEEN IMPLANTED FOR 4 DAYS. THE HYDROPICC WAS REPLACED ON THE SAME DAY WITH ANOTHER HYDROPICC INTO THE LEFT BRACHIAL VEIN, AND SECURED WITH A 5FR SECURACATH. NO ISSUES WERE NOTED WITH THE REPLACEMENT PROCEDURE. A REVIEW OF LOT #09032001, INCLUDING THE ASSOCIATED LOT RELEASE DATA, WAS PERFORMED AND DID NOT REVEAL ANY NOTATIONS, COMMENTS, OR ISSUES, WHICH COULD BE ATTRIBUTED TO THE CAUSE OF THE REPORTED PROBLEM. THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 1 DAY AFTER BEING IMPLANTED, THE HYDROPICC WAS UNABLE TO BE FLUSHED, AND THAT A GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE CATHETER. THE CATHETER WAS EXPLANTED WHERE A KNOT WAS OBSERVED AT THE DISTAL END OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152650 HYDROPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ACCESS VASCULAR, INC. PICC-142 09032001 00862559000418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other