BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURB, SHERLOCK 3CG TCS

    MDR report key: 10028297 · Received May 6, 2020

    Report

    Report Number
    3006260740-2020-01646
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Report Date
    May 6, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741125300
    PMA / PMN Number
    K113808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 1

    PER PICC RN - SENSOR IS GIVING ERRONEOUS MAGNET TRACKING INFORMATION. TODAY IT SHOWED THE PICC GOING UP INTO THE IJ, YESTERDAY IT SHOWED IT WAS PROPERLY PLACED IN THE CAJ BUT THE XRAY SHOWED IT UP IN THE IJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493045 REFURB, SHERLOCK 3CG TCS CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS 9770131R NA 00801741125300

    Patients

    Seq Age Sex Outcome Treatment
    1