BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV CATHETER

    MDR report key: 3871591 · Received June 13, 2014

    Report

    Report Number
    1118880-2014-00020
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 4, 2010
    Report Date
    June 13, 2014
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    FOZ
    PMA / PMN Number
    K891087
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - INVOLVED DEVICE IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED, WHICH PREVENTED REVIEW OF APPLICABLE PRODUCTION OR COMPLAINT RECORDS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SURFLO GREEN 18 GAUGE IV CATHETER BROKE IN THE PATIENTS LEFT ARM. FOLLOW-UP COMMUNICATIONS CONFIRMED, ALL PRODUCT BELOW THE SKIN LINE ESTIMATED AT BEING 1"-2" TRAVELED THROUGH THE VEIN IN THE LEFT ARM TO THE LEFT SHOULDER, THEN THROUGH THE PATIENT'S HEART AND IS PERMANENTLY LODGED IN THE CENTER OF THE UPPER LEFT LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350253 IV CATHETER INTRODUCER CATHETER FOZ TERUMO MEDICAL CORPORATION NA UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention