BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 3874618 · Received April 24, 2014

    Report

    Report Number
    3006260740-2014-00208
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 31, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS REC'D THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT, THE SECOND TIME CHEMOTHERAPY, VESSEL OF THE PATIENT IS GOOD. ON (B)(6) 2013, BASILIC CATHETER ON THE RIGHT SIDE UNDER ULTRASOUND. THE PATIENT WAS INSERTED AND CARED IN OTHER HOSPITAL BEFORE, AND WAS CARED IN THIS CANCER HOSPITAL FOR THE FIRST TIME. CHIEF COMPLAINT OF THE PATIENT IS PAIN IN THE ARM. THEN THE CATHETER WAS REMOVED AND OUTFLOW WAS FOUND 3CM ABOVE THE PUNCTURE POINT. THEREFORE, REMOVED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248129 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY LJS C.R. BARD, INC. (BASD) REXC1885

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention