BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC

    MDR report key: 12561306 · Received October 1, 2021

    Report

    Report Number
    12561306
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 21, 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

    INTERNAL ELECTROCARDIOGRAM (ECG) NOT WORKING WITH BARD ACCESS SYSTEMS, INC. POWERPICC PERIPHERALLY-INSERTED CENTRAL VENOUS CATHETER DURING INSERTION. DEFECTIVE INTERNAL STYLE WIRE VS ECG LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460711 POWERPICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. 1174108D4 3548

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA