BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD Y INJECTION SITE OL

    MDR report key: 1133057 · Received August 22, 2008

    Report

    Report Number
    9613251-2008-00301
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 28, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICES WILL NOT BE RETURNED FOR INVESTIGATION. 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 UNRESTRICTED FLOW. THE TUBING SETS WERE BEING USED TO DELIVER SALINE AND UNSPECIFIED RADIOACTIVE NUCLEOTIDES. THE CAIR CLAMPS WERE BEING USED TO REGULATE THE FLOWS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE CLINICIANS NOTED THE FLOW RATES HAD CHANGED. THE CLINICIANS EITHER READ JUST THE FLOW RATES USING THE CAIR CLAMPS OR REPLACED THE TUBING SETS AND THE PROCEDURES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD Y INJECTION SITE OL 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK