BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3113351 · Received April 24, 2013

    Report

    Report Number
    3113351
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 24, 2013
    Manufacturer
    *
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    WHEN IV TUBING WAS DISCONTINUED TO FLUSH PATIENT'S IV, THE TIP OF THE SMALL EXTENSION AND 7" SMALL BORE PRESSURE INFUSION SET WITH THE CLEAR MICROCLAVE, PURPLE CLAMP BROKE OFF AT THE POINT OF CONNECTION INTO THE HOSPIRA J-LOOP EXTENSION SET. THIS RESULTED IN A WHOLE NEW J-LOOP NEEDING TO BE APPLIED TO THE HUB OF THE IV CANNULA. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV TUBING WAS DISCONTINUED TO FLUSH PATIENT'S IV.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177781 * TUBING, FLUID DELIVERY FPK * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR