BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9FR DUAL LUMEN POLYURETHANE PIC CATHETER

    MDR report key: 20705742 · Received November 18, 2024

    Report

    Report Number
    20705742
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 28, 2024
    Manufacturer
    FOOTPRINT MEDICAL, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN PREPPING FOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE INSERTION, NOTICED SOME DISCOLORATION IN THE CATHETER. UPON FURTHER OBSERVATION NOTED A CRACK IN THE CATHETER AROUND THE 8 CM MARK. PICC CATHETER SIZE1.9FR AND LOT#231329. A NEW CATHETER WAS OBTAINED FOR INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118767 1.9FR DUAL LUMEN POLYURETHANE PIC CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL, INC. P2PIC1.9-C 231329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown