BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC

    MDR report key: 20332411 · Received September 30, 2024

    Report

    Report Number
    20332411
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 12, 2024
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING BEDSIDE PICC PLACEMENT, NOTED THE SHERLOCK WAS NEVER RELIABLE. IT KEPT BOUNCING AROUND, NEVER WENT DOWN AS EXPECTED. NEVER TURNED GREEN. CXR (CHEST X-RAY) SHOWED CAJ (CAVOATRIAL JUNCTION). PICC LINE CONFIRMED IN PROPER PLACEMENT. WIRES RETAINED IF DESIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607117 POWERPICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. 1174108D5 REJQ1423

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other