BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS CLAVE NDHP MICR

    MDR report key: 2822794 · Received November 2, 2012

    Report

    Report Number
    9613251-2012-00215
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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 SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE OPENED POSITION. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. AT UNSPECIFIED TIMES, IT WAS REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT OF THE TUBING SETS REMAINED IN THE OPENED POSITION. THE CUSTOMER CONTACT REPORTED THAT SOLUTION LEAKED AND UNSPECIFIED VOLUMES OF BLOOD LOSS WERE NOTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAYS IN THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CLAVE NDHP MICR 80FPA FPA HOSPIRA LTD. NA 15106NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK