BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT INTRODUCER KIT

    MDR report key: 7244264 · Received February 6, 2018

    Report

    Report Number
    7244264
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    November 24, 2017
    Report Date
    January 17, 2018
    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 IN FOR CADD DISCONNECT, STATING AT 4 A.M. WHEN HE GOT UP TO USE THE BR HE FELT LIKE HIS SHIRT WAS WET AND NOTICED THAT THE TUBING FOR PORT ACCESS TO THE CHEMO BALL WAS BROKEN AND BLOOD WAS COMING OUT OF TUBING PROXIMAL TO PORT SITE. HE STATES THAT HE HAD TO CUT THE TUBING TO GET THE CLAMP TO STOP THE BLOOD FROM COMING OUT OF THE PORT. PATENT STATES THE BALL WAS FLAT AT THIS TIME AND A VERY SMALL AMOUNT OF CHEMO WAS SPILLED. PATIENT STATES THAT THEY USED THE SPILL KIT TO CLEAN UP THE SPILL. PATIENT STATES THAT HE WENT TO THE ER TO BE EVALUATED. THE ER LEFT THE PORT NEEDLE IN PLACE AND PATIENT CAME TO UNIT TO BE DE ACCESSED. PORT NEEDLE TAKEN OUT DUE TO NO PLACE FOR IT TO BE ACCESSED AND FLUSHED. PATIENT THEN RE ACCESSED AND FLUSHED PER PROTOCOL WITH NO DIFFICULTIES. PATIENT INSTRUCTED TO BAG UP HIS CLOTHING FROM THE SPILL UNTIL RN COULD FURTHER INVESTIGATE WHAT APPROPRIATE ACTION TO TAKE WITH THE CLOTHING. MD MADE AWARE, WITH NO NEW ORDERS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87832 PORT INTRODUCER KIT OKE CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT KNOWN.