BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM T CONNECTOR

    MDR report key: 1920803 · Received November 24, 2010

    Report

    Report Number
    1920803
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 24, 2010
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    DURING THE NURSE'S HOURLY CHECKS, SHE DISCOVERED BLOOD AND IV FLUIDS IN THE BED. ON FURTHER INSPECTION OF THE IV LINE, SHE NOTED THE IV EXTENSION SET CAME APART AT THE MICROCLAVE CONNECTION. THE PATIENT DID NOT PULL ON THE LINE, IT CAME APART WITH HIM MOVING ABOUT THE BED. (BELOW BLUE PORT OF T-CONNECTOR, JUST CAME APART)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM T CONNECTOR IV SET, CONNECTOR, T CONNECTOR FPA HOSPIRA Z2714 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *