BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE PORT MICRO EXTENSION SET - 7" INT

    MDR report key: 1023684 · Received April 1, 2008

    Report

    Report Number
    9613251-2008-00077
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 12, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SALE LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING SET. THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED POWER INJECTOR AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONTRAST MEDIA DURING A CT SCAN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED THAT AIR IN BLOOD WAS DETECTED IN THE CT IMAGE. THE CUSTOMER CONTACT INDICATED THAT 0.5ML OF AIR WAS DELIVERED TO THE PT; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE PORT MICRO EXTENSION SET - 7" INT 80-FPA FPA HOSPIRA LTD. NA 56058NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED POWER INJECTOR, MFR'D BY E-Z-EM