BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT INTRODUCER KIT

    MDR report key: 7159693 · Received January 3, 2018

    Report

    Report Number
    7159693
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 4, 2017
    Report Date
    December 19, 2017
    Manufacturer
    CARDINAL HEALTH
    Product Code
    OKE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONNECTED TO ELASTOMERIC PUMP CONTAINING 5FU FOR CONTINUOUS HOME INFUSION. PATIENT REPORTED TO THE CHEMO INFUSION CENTER AROUND 11 AM TO HAVE HIS FANNY PACK REPLACED AS THE ZIPPER HAD BROKEN. AT THAT TIME, EVERYTHING WAS WORKING PROPERLY. AROUND 2PM THE PATIENT REPORTED BACK AT THE INFUSION DEPARTMENT BECAUSE THE TUBING FROM THE 5FU PUMP HAD BECOME DISCONNECTED FROM THE TUBING ON THE HUBER NEEDLE. UPON EXAMINING THE PATIENT AND THE EQUIPMENT, THE CLAVE CONNECTOR HAD BECOME LOOSENED TO THE POINT IT CAME DISCONNECTED FROM THE HUBER NEEDLING TUBING. SUBSEQUENTLY THE PATIENT HAD CHEMOTHERAPY ON HIS CLOTHING. BECAUSE THE VASCULAR ACCESS WAS COMPROMISED, THE HUBER NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6531 PORT INTRODUCER KIT OKE CARDINAL HEALTH 435984

    Patients

    Seq Age Sex Outcome Treatment
    1