BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.9 FR PICC

    MDR report key: 1205783 · Received October 17, 2008

    Report

    Report Number
    2925153-2008-00005
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NEOMEDICAL INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1.9 FR CATHETER IS A SILICONE CATHETER AND THE IFU STATES "SILICONE CATHETERS ARE FRAGILE AND MUST BE HANDLED WITH CARE. DRESS AND ANCHOR THE CATHETER TO THE PT USING MFR'S GUIDELINE." THE PRODUCT IFU GIVES CLEAR DIRECTIONS CONCERNING CATHETER SECUREMENT; IT STATES "CAUTION: NEVER PLACE TAPE OVER THE CATHETER TUBING. THIS WILL COMPROMISE THE STRENGTH AND INTEGRITY OF THE TUBING." THE USER APPARENTLY DID NOT FOLLOW THE IFU INSTRUCTIONS. ADD'L INFO HAS BEEN REQUESTED CONCERNING THE PT AND THE DETAILS OF THE REPORT. THE USED SAMPLE WAS SENT FOR STERILIZATION AND CANNOT BE LOCATED.

    Description of Event or Problem · 1

    BASED ON THE REPORT, RECEIVED VIA MAIL IN 2008, AT HOSPITAL, THE PICC LINE BROKE DUE TO NURSE PLACING STERI-STRIPS OVER THE AREA OF THE BREAK AND WHILE INFORMED AND TRAINED NOT TO, THE STERI-STRIPS WERE STILL PLACED ANYWAY. NO ADD'L INFO HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9 FR PICC V-CATH, NEOMAGIC LJS NEOMEDICAL INC. RDTS-499 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention