BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE CLEAR

    MDR report key: 3250770 · Received May 2, 2013

    Report

    Report Number
    3250770
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RN WAS DISCONNECTING PATIENT TO HEP-LOCK HER PICC LINE. THE END OF THE TUBING WAS VERY HARD TO DISCONNECT FROM THE PATIENT. THE TUBING ON THE END OF THE TUBING THAT CONNECTED DIRECTLY TO THE PATIENT'S PICC LINE WAS THE EXTENSION TUBING WITH THE PURPLE CLAMP. UPON CLOSER ASSESSMENT, THIS RN NOTED A CRACK IN THE LEURLOCK HOUSING OF THE EXTENSION WITH THE PURPLE CLAMP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEP-LOCK PICC LINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193799 MICROCLAVE CLEAR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR