BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC

    MDR report key: 11919391 · Received June 2, 2021

    Report

    Report Number
    11919391
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSERTING A BARD ACCESS SYSTEMS 5 FR. DUAL LUMEN POWERPICC TO RIGHT BRACHIAL VEIN. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS OBSERVED GOING DOWN TO THE SUPERIOR VENA CAVA PER 3CG SHERLOCK TECHNOLOGY. INTRATHORACIC WAVE FORM WAS NOT VISIBLE ON MONITOR. REMOVED 3CG INNER WIRE TO RECALIBRATE. UPON VISUALIZATION, THE LAST 4 CM OF THE INNER WIRE WERE OBSERVED HANGING OFF OF THE REST OF THE WIRE. A NEW WIRE WAS RETRIEVED TO FINISH THE PROPER PLACEMENT OF THE PICC LINE. CHEST X-RAY WAS TAKEN AND NO FOREIGN OBJECT WAS VISUALIZED IN THE CHEST CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818014 POWERPICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. CK000758 REEV1525

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA