BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.6F X 50CM DUAL VASCU-PICC

    MDR report key: 11640571 · Received April 9, 2021

    Report

    Report Number
    11640571
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 2, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLACED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). X-RAY OBTAINED. PULLED BACK PICC CATHETER AND CATHETER UNABLE TO FLUSH. REMOVED PICC LINE AND PICC WAS FOUND TO BE CRACKED. AFTER INSERTION OF LINE, ON ATTEMPT TO FLUSH, MET RESISTANCE, AFTER TROUBLESHOOTING, LINE WAS PULLED AND THERE WAS A CRACK IN THE LINE. EASILY IDENTIFIED, JUST OVER 2CM FROM THE CUT TIP OF THE CATHETER. THIS EVENT HAD MINIMAL TEMPORARY HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536999 2.6F X 50CM DUAL VASCU-PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS, INC. MD17012601 MPFF010

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA