BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LUMEN 1.4FR POLYURETHANE PIC CATHETER

    MDR report key: 9613172 · Received January 21, 2020

    Report

    Report Number
    3007697249-2020-00002
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    November 15, 2019
    Report Date
    January 21, 2020
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Product Code
    LJS
    UDI-DI
    00858778006058
    PMA / PMN Number
    K130507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT #170942 WAS REVIEWED. ALL CATHETERS PASSED IN-PROCESS AND FINAL INSPECTION CRITERIA INCLUDING LEAK TESTING. THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. THE CATHETER EVIDENCED APPARENT SIGNS OF BREAK IN TENSION. BROKEN PORTION OF CATHETER WAS REMOVED IN RADIOLOGY AND THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    THE PICC LINE BROKE DURING ATTEMPTED EXTRACTION. THE BROKEN PORTION OF THE CATHETER WAS REMOVED BY RADIOLOGIST. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76798 SINGLE LUMEN 1.4FR POLYURETHANE PIC CATHETER PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER LJS FOOTPRINT MEDICAL INC. P1PIC1.4-C 170942 00858778006058

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Required Intervention