BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP LS MICRBR CLAVE

    MDR report key: 3832599 · Received March 17, 2014

    Report

    Report Number
    9613251-2014-00063
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 24, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WERE DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED SILICONE SLEEVE OF THE CLAVE PORTS REMAINED IN THE DEPRESSED POSITION WERE IDENTIFIED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE SILICONE SLEEVE OF THE CLAVE PORT ON EXTENSION TUBING SETS REMAINED IN THE DEPRESSED POSITION. ON UNSPECIFIED DATES, THE CUSTOMER CONTACT REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT ON EXTENSION TUBING SETS REMAINED IN THE DEPRESSED POSITION. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156890 NDHP LS MICRBR CLAVE 80FPK FPK HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK